WARNING - FDA records indicate that this drug has been recalled.

Shamrock Medical Solutions Group LLC

Product Description:	metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01
Status:	Completed
City:	Lewis Center
State:	OH
Country:	US
Voluntary/Mandated:	Voluntary: Firm Initiated
Initial Firm Notification:	Telephone
Distribution Pattern:	Product was shipped to the following states: CO, MA, OH, TX & WY.
Classification:	Class I
Product Quantity:	88/5 mg tablets
Reason For Recall:	Labeling: Label Mix up; product labeled did not indicated Extended Release
Recall Initiation Date:	20110927
Report Date:	20140730

Pain Relief

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Side Effects & Adverse Reactions

Warnings: Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Directions: FOR ORAL USE.

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History

There is currently no drug history available for this drug.

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Other Information

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Sources

Pain Relief Manufacturers

Safeway

Pain Relief | Uriel Pharmacy Inc.

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

do not take more than directed (see Liver warning) adults and children 12 years and over take 2 tablets every 6 hours as needed do not take more than 8 tablets in 24 hours children under 12 years do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Active Release Techniques Llc

Pain Relief | Active Release Techniques Llc

Directions
adults and children 2 years of age and older: apply to affected are not more than 3 to 4 times daily children under 2 years of age: consult a physician

No Recall
Cvs Pharmacy

Pain Relief | Cvs Pharmacy

do not take more than directed (see Liver warning) adults and children 12 years and over

take 2 tablets every 6 hours as needed do not take more than 8 tablets in 24 hours children under 12 years do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Hyvee Inc

Pain Relief | Hyvee Inc

do not take more than directed (see Liver warning) adults and children 12 years and over

take 2 tablets every 6 hours as needed do not take more than 8 tablets in 24 hours children under 12 years do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

do not take more than directed (see Liver warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours
children
6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours
children under
6 years do not use this adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Safeway

Pain Relief | Safeway

use only as directed adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

No Recall
Walgreen Company

Pain Relief | Walgreen Company

do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dropper designed for use with this product. Do not use any other dosing device. fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace dropper tightly to maintain child resistance this product does not contain directions or complete warnings for adult use Dosing Chart Weight(lb) Age(yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1.6 mL (0.8 + 0.8 mL)
Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.

No Recall
Cvs Pharmacy

Pain Relief | Cvs Pharmacy

adults and children over 12 years
apply generously to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, not more than 3 to 4 times daily
children 12 years or younger ask a doctor

No Recall
Rite Aid Corporation

Pain Relief | Rite Aid Corporation

do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dropper designed for use with this product. Do not use any other dosing device. fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace dropper tightly to maintain child resistance this product does not contain directions or complete warnings for adult use Dosing Chart Weight(lb) Age(yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1.6 mL (0.8 + 0.8 mL)
Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dropper designed for use with this product. Do not use any other dosing device. fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace dropper tightly to maintain child resistance this product does not contain directions or complete warnings for adult use Dosing Chart Weight(lb) Age(yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1.6 mL (0.8 + 0.8 mL)
Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.

No Recall
Kroger Company

Pain Relief | Kroger Company

do not take more than directed (see Liver warning) adults and children 12 years and over take 2 geltabs every 6 hours while symptoms last do not take more than 6 geltabs in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1 tsp or 5 mL 36–47 4–5 years 1 1/2 tsp or 7.5 mL 48–59 6–8 years 2 tsp or 10 mL 60-71 9–10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Western Family Foods Inc

Pain Relief | Western Family Foods Inc

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1 tsp or 5 mL 36-47 4-5 years 1 1/2 tsp or 7.5 mL 48-59 6-8 years 2 tsp or 10 mL 60-71 9-10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2-3 years 1 tsp or 5 mL 36-47 4-5 years 1 ½ tsp or 7.5 mL 48-59 6-8 years 2 tsp or 10 mL 60-71 9-10 years 2 ½ tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Kmart Corporation

Pain Relief | Kmart Corporation

do not take more than directed (see overdose warning) swallow whole – do not crush, chew or dissolve
adults and children
12 years and over take 2 caplets every 6 hours as needed do not take more than 8 caplets in 24 hours do not use for more than 10 days unless directed by a doctor children under 12 years do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Kareway Product, Inc.

Pain Relief | Kareway Product, Inc.

Adults and children 12 years of age and over:

clean and dry affected area remove patch from film apply to affected area not more than 3 to 4 times daily for 7 days wear up to 8 hours per application Children under 12 years of age:
consult a doctor

No Recall
Publix Super Markets Inc

Pain Relief | Publix Super Markets Inc

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of the bottle tip the bottle upside down and draw medicine into the syringe fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace cap tightly to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL
Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise, use age. use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor
Weight(lb) Age(yr) Dose (tsp or mL) under 24 under 2 years ask a doctor 24-35 2–3 years 1 tsp or 5 mL 36–47 4–5 years 1 1/2 tsp or 7.5 mL 48–59 6–8 years 2 tsp or 10 mL 60-71 9–10 years 2 1/2 tsp or 12.5 mL 72-95 11 years 3 tsp or 15 mL
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Safetec Of America, Inc.

Pain Relief | Safetec Of America, Inc.

adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor. consult a dentist or doctor for use on children under 2 years of age children under 12 years of age should be supervised in the use of this product

No Recall
Hyvee Inc

Pain Relief | Qualitest Pharmaceuticals

2.1 Adult Hypertension
The recommended starting dose of valsartan tablets is 80 mg or 160 mg once daily when used as monotherapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valsartan tablets may be used over a dose range of 80 mg to 320 mg daily, administered once a day.
The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg.
No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of valsartan tablets in patients with hepatic or severe renal impairment.

Valsartan tablets may be administered with other antihypertensive agents.
Valsartan tablets may be administered with or without food.
2.2 Pediatric Hypertension 6 to 16 years of age
For children who can swallow tablets, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total). The dosage should be adjusted according to blood pressure response. Doses higher than 2.7 mg/kg (up to 160 mg) once daily have not been studied in pediatric patients 6 to 16 years old.
For children who cannot swallow tablets, or children for whom the calculated dosage (mg/kg) does not correspond to the available tablet strengths of valsartan tablets , the use of a suspension is recommended. Follow the suspension preparation instructions below (see Preparation of Suspension) to administer valsartan as a suspension. When the suspension is replaced by a tablet, the dose of valsartan may have to be increased. The exposure to valsartan with the suspension is 1.6 times greater than with the tablet.
No data are available in pediatric patients either undergoing dialysis orwith a glomerular filtration rate <30 mL/min/1.73 m2[see Pediatric Use (8.4)].
valsartan tablets are not recommended for patients <6 years old [see Adverse Reactions (6.1), Clinical Trials (14.1)].
Preparation of Suspension (for 160 mL of a 4 mg/mL suspension)
Add 80 mL of Ora-Plus®* oral suspending vehicle to an amber glass bottle containing 8 tablets of Valsartan 80 mg, and shake for a minimum of 2 minutes. Allow the suspension to stand for a minimum of 1 hour. After the standing time, shake the suspension for a minimum of 1 additional minute. Add 80 mL of Ora-Sweet SF®* oral sweetening vehicle to the bottle and shake the suspension for at least 10 seconds to disperse the ingredients. The suspension is homogenous and can be stored for either up to 30 days at room temperature (below 30°C/86°F) or up to 75 days at refrigerated conditions (2 to 8°C/35 to 46°F) in the glass bottle with a child-resistant screw-cap closure. Shake the bottle well (at least 10 seconds) prior to dispensing the suspension.
*Ora-Sweet SF® and Ora-Plus® are registered trademarks of Paddock Laboratories, Inc.
2.3 Heart Failure
The recommended starting dose of valsartan tablets is 40 mg twice daily. Uptitration to 80 mg and 160 mg twice daily should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses.

No Recall
Kroger Company

Pain Relief | Kroger Company

do not take more than directed (see Liver warning)
adults and children 12
years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Kroger Company

Pain Relief | Kroger Company

do not take more than directed (see Liver warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Cvs Pharmacy

Pain Relief | Johnson & Johnson Consumer Inc.

adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician. children 2-6 years use a pea sized amount instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision. children under 2 years of age: ask a dentist or doctor

No Recall
P And L Development Of New York Corporation

Pain Relief | P And L Development Of New York Corporation

Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used. do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor
:

No Recall
P And L Development Of New York Corporation

Pain Relief | P And L Development Of New York Corporation

Directions do not take more than directed the smallest effective dose should be used Adults and children 12 years and older take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used. do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor
:

No Recall
Select Corporation

Pain Relief | Select Corporation

Directions: • do not take more than directed • the smallest effective dose should be used • adults and children 12 years and over: • take 1 tablet every 4 to 6 hours while symptoms persist • if pain or fever does not respond to 1 tablet, 2 tablets may be used • do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: • ask a doctor

No Recall
Cvs Pharmacy

Pain Relief | Cvs Pharmacy

• do not take more than directed (see Liver warning)
adults and children

12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Publix Super Markets Inc

Pain Relief | Publix Super Markets Inc

• do not take more than directed (see Liver warning)
adults and children 12 years and over
• take 2 gelcaps every 6 hours while symptoms last • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
H E B

Pain Relief | American Health Packaging

Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with hydrocodone bitartrate and ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient's needs.

For the short-term (generally less than 10 days) management of acute pain, the recommended dose of hydrocodone bitartrate and ibuprofen tablets is one tablet every 4 to 6 hours, as necessary. Dosage should not exceed 5 tablets in a 24-hour period. It should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The lowest effective dose or the longest dosing interval should be sought for each patient (see WARNINGS), especially in the elderly. After observing the initial response to therapy with hydrocodone bitartrate and ibuprofen tablets, the dose and frequency of dosing should be adjusted to suit the individual patient's need, without exceeding the total daily dose recommended.

No Recall
H E B

Pain Relief | H E B

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours
Weight (lb)

Age (yr)

Dose (mL or tsp)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 tsp)

36-47

4-5 years

7.5 mL (1 ½ tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
H E B

Pain Relief | Apotheca Company

DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

• do not take more than directed (see Liver warning)
adults and children 12 years and over
• take 2 gelcaps every 6 hours while symptoms last • do not take more than 6 gelcaps in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Walgreen Company

Pain Relief | Walgreen Company

• do not take more than directed • the smallest effective dose should be used • drink a full glass of water with each dose
Adults and children 12 years and older
• take 1 caplet every 8 to 12 hours while symptoms last • for the first dose you may take 2 caplets within the first hour • do not exceed 2 caplets in any 8- to 12-hour period • do not exceed 3 caplets in a 24-hour period
Children under 12 years
• ask a doctor

No Recall
P And L Development Of New York Corporation

Pain Relief | P And L Development Of New York Corporation

Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

No Recall
Western Family Foods Inc

Pain Relief | American Health Packaging

There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin HCl extended-release tablets, USP or any other pharmacologic agent. Dosage of metformin HCl extended-release tablets, USP must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin HCl extended-release tablets, USP in adults is 2000 mg.

Metformin HCl extended-release tablets, USP should generally be given once daily with the evening meal. Metformin HCl extended-release tablets, USP should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.

During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin HCl extended-release tablets, USP and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin HCl extended-release tablets, USP, either when used as monotherapy or in combination with sulfonylurea or insulin. Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.

Short-term administration of metformin HCl extended-release tablets, USP may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.

Metformin HCl extended-release tablets, USP must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of metformin HCl extended-release tablets, USP will be eliminated in the feces as a soft, hydrated mass. (See Patient Information printed below.)

Recommended Dosing Schedule

Adults - In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.

The usual starting dose of metformin HCl extended-release tablets, USP is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on metformin HCl extended-release tablets, USP 2000 mg once daily, a trial of metformin HCl extended-release tablets, USP 1000 mg twice daily should be considered. (See CLINICAL PHARMACOLOGY, Clinical Studies.)

Pediatrics - Safety and effectiveness of metformin HCl extended-release tablets, USP in pediatric patients have not been established.

Transfer From Other Antidiabetic Therapy

When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin HCl extended-release tablets, USP, no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.

Concomitant Metformin HCl Extended-Release Tablets, USP and Oral Sulfonylurea Therapy in Adult Patients

If patients have not responded to four weeks of the maximum dose of metformin HCl extended-release tablets, USP monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin HCl extended-release tablets, USP at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide).

With concomitant metformin HCl extended-release tablets, USP and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. With concomitant metformin HCl extended-release tablets, USP and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.)

If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin HCl extended-release tablets, USP and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin HCl extended-release tablets, USP.

Concomitant Metformin HCl Extended-Release Tablets, USP and Insulin Therapy in Adult Patients

The current insulin dose should be continued upon initiation of metformin HCl extended-release tablets, USP therapy. Metformin HCl extended-release tablets, USP therapy should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin HCl extended-release tablets, USP should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2000 mg for metformin HCl extended-release tablets, USP. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin HCl extended-release tablets, USP. Further adjustment should be individualized based on glucose-lowering response.

Specific Patient Populations

Metformin HCl extended-release tablets, USP are not recommended for use in pregnancy. Metformin HCl extended-release tablets, USP are not recommended in pediatric patients (below the age of 17 years).

The initial and maintenance dosing of metformin HCl extended-release tablets, USP should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of metformin HCl extended-release tablets, USP.

Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (See WARNINGS.)

Recall
Hyvee Inc

Pain Relief | Hyvee Inc

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1 ½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2 ½ tsp) 72-95 11 years 15 mL (3 tsp)
*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Publix Super Markets Inc

Pain Relief | Publix Super Markets Inc

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter • find right dose on chart. If possible, use weight to dose; otherwise use age. • push air out of syringe. Firmly push syringe into bottle opening. • turn bottle upside down. Pull syringe to the first dose line and then push product back into bottle. • pull syringe until it reaches and stays at the correct dose • dispense liquid slowly into child’s mouth, toward inner cheek • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours • replace cap tightly to maintain child resistance
Dosing Chart

Weight (lb)

Age (yr)

Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

*or as directed by a doctor

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

No Recall
Genuine Virgin Aloe Corporation

Pain Relief | Genuine Virgin Aloe Corporation

DIRECTIONS:
APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 3 TO 4 TIMES A DAY. FOR USE ON ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER. CHILDREN UNDER 2 YEARS - ASK A DOCTOR.

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

• do not take more than directed (see overdose warning)
adults and children 12 years and over
• take 2 tablets every 6 hours while symptoms last • do not take more than 6 tablets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Hyvee Inc

Pain Relief | Hyvee Inc

• do not take more than directed (see Liver warning)
adults and children 12 years and over
• take 2 tablets every 6 hours while symptoms last • do not take more than 6 tablets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

• do not take more than directed (see overdose warning)
adults and children 12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Shopko Stores Operating Co., Llc

Pain Relief | Shopko Stores Operating Co., Llc

• do not take more than directed (see overdose warning)
adults and children 12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Western Family Foods Inc

Pain Relief | Western Family Foods Inc

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1 ½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2 ½ tsp) 72-95 11 years 15 mL (3 tsp)
*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

• do not take more than directed (see Liver warning)
adults and children 12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Hyvee Inc

Pain Relief | Hyvee Inc

• do not take more than directed (see overdose warning)
adults and children

12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under

12 years

ask a doctor

No Recall
Bio-pharm, Inc.

Pain Relief | Bio-pharm, Inc.

This product does not contain directions or complete warnings for adult use. find right dose on chart if needed, repeat dose every 4 hours if possible, use weight to dose; otherwise, use age do not use more than 5 times in 24 hour use only enclosed dosing cup to dose this product Weight Age Dose under 24 lbs under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 1 TSP (5 mL) 36 to 47 lbs 4 to 5 years 1 1/2 TSP (7.5 mL) 48 to 59 lbs 6 to 8 years 2 TSP (10 mL) 60 to 71 lbs 9 to 10 years 2 1/2 TSP (12.5 mL) 72 to 95 lbs 11 years 3 TSP (15 mL)

No Recall
H E B

Pain Relief | Walgreen Company

• this product does not contain directions or complete warnings for adult use • do not give more than directed (see overdose warning) • shake well before using • mL = milliliter; tsp = teaspoonful • find right dose on chart below. If possible, use weight to dose; otherwise, use age. • remove the child protective cap and squeeze your child’s dose into the dosing cup • repeat dose every 4 hours while symptoms last • do not give more than 5 times in 24 hours
Weight (lb)

Age (yr)

Dose (mL or tsp)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL (1 tsp)

36-47

4-5 years

7.5 mL (1 ½ tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 ½ tsp)

72-95

11 years

15 mL (3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

No Recall
Publix Super Markets Inc

Pain Relief | Pd-rx Pharmaceuticals, Inc.

2.1 Epilepsy
It is not necessary to monitor topiramate plasma concentrations to optimize topiramate tablets therapy.

On occasion, the addition of topiramate tablets to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with topiramate tablets may require adjustment of the dose of topiramate tablets.

Because of the bitter taste, tablets should not be broken.

Topiramate tablets can be taken without regard to meals.

Monotherapy Use

Adults and Pediatric Patients 10 Years and Older

The recommended dose for topiramate monotherapy in adults and pediatric patients 10 years of age and older is 400 mg/day in two divided doses. Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day. The dose should be achieved by titration according to the following schedule:
Table 1: Monotherapy Titration Schedule for Adults and Pediatric Patients 10 years and older
Morning Dose
Evening Dose
Week 1
25 mg
25 mg
Week 2
50 mg
50 mg
Week 3
75 mg
75 mg
Week 4
100 mg
100 mg
Week 5
150 mg
150 mg
Week 6
200 mg
200 mg

Children Ages 2 to <10 Years

Dosing of topiramate as initial monotherapy in children 2 to < 10 years of age with partial onset or primary generalized tonic-clonic seizures was based on a pharmacometric bridging approach [see Clinical Studies (14.1)].

Dosing in patients 2 to <10 years is based on weight. During the titration period, the initial dose of topiramate tablets should be 25 mg/day administered nightly for the first week. Based upon tolerability, the dosage can be increased to 50 mg/day (25 mg twice daily) in the second week.Dosage can be increased by 25-50 mg/day each subsequent week as tolerated. Titration to the minimum maintenance dose should be attempted over 5-7 weeks of the total titration period.Based upon tolerability and seizure control, additional titration to a higher dose (up to the maximum maintenance dose) can be attempted at 25-50 mg/day weekly increments. The total daily dose should not exceed the maximum maintenance dose for each range of body weight (Table 2).
Table 2: Monotherapy Target Total Daily Maintenance Dosing for Patients 2 to <10 Years * Administered in two equally divided doses

Weight (kg)

Total Daily Dose
(mg/day)*
Minimum
Maintenance
Dose
Total Daily Dose
(mg/day)*
Maximum
Maintenance Dose
Up to 11
150
250
12 – 22
200
300
23 – 31
200
350
32-38
250
350
Greater than 38
250
400

Adjunctive Therapy Use

Adults (17 Years of Age and Over) - Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of topiramate tablets as adjunctive therapy in adults with partial onset seizures is 200 to 400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. It is recommended that therapy be initiated at 25 to 50 mg/day followed by titration to an effective dose in increments of 25 to 50 mg/day every week. Titrating in increments of 25 mg/day every week may delay the time to reach an effective dose. Doses above 400 mg/day (600, 800 or 1,000 mg/day) have not been shown to improve responses in dose-response studies in adults with partial onset seizures. Daily doses above 1,600 mg have not been studied.

In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose was reached at the end of 8 weeks [see Clinical Studies (14.1)].

Pediatric Patients (Ages 2 - 16 Years) – Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of topiramate tablets as adjunctive therapy for pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg/day (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.

In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose of 6 mg/kg/day was reached at the end of 8 weeks [see Clinical Studies (14.1)].
2.4 Patients with Renal Impairment
In renally impaired subjects (creatinine clearance less than 70 mL/min/1.73 m2), one-half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.
2.5 Geriatric Patients (Ages 65 Years and Over)
Dosage adjustment may be indicated in the elderly patient when impaired renal function (creatinine clearance rate <70 mL/min/1.73 m2) is evident [see Clinical Pharmacology (12.3)].
2.6 Patients Undergoing Hemodialysis
Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.
2.7 Patients with Hepatic Disease
In hepatically impaired patients, topiramate plasma concentrations may be increased. The mechanism is not well understood.

No Recall
Meijer Distribution Inc

Pain Relief | Meijer Distribution Inc

• do not use more than directed (see Liver warning)
adults and children

12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Hyvee Inc

Pain Relief | Hyvee Inc

• do not take more than directed (see overdose warning)
adults and children 12 years and over
• take 2 tablets every 6 hours while symptoms last • do not take more than 6 tablets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Shopko Stores Operating Co., Llc

Pain Relief | Kroger Company

• take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over

2 softgels with water every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

No Recall
Hyvee Inc

Pain Relief | Hyvee Inc

• do not take more than directed (see overdose warning)
adults and children 12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under

12 years

ask a doctor

No Recall