Childrens Pain Relief

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Childrens Pain Relief Recall

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Side Effects & Adverse Reactions

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Liver warning: This product contains acetaminophen Severe liver damage may occur if your child takes:

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanyed or followed by fever,headache, rash, nausea, or vomiting, consult a doctor prompty.

Do not use

with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

When using this product,

do not exceed recommended dose (see overdose warning).

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Do not use

with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if your child has

liver disease.

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

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

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Uses

temporarily reduces fever
temporarily relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Childrens Pain Relief Manufacturers

Quality Choice (Chain Drug Marketing Association)

Childrens Pain Relief | Quality Choice (chain Drug Marketing Association)

this product does not contain directions or complete warnings for adult use do not take more than directed (see overdose warning) shake well before using mL = milliliter; tsp = teaspoon find the right dose on chart below. If possible, use weight to dose; otherwise, use age use only the enclosed dosing cup designed for use with 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 more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 ask a doctor 24-35 2-3 5 mL (1tsp) 36-47 4-5 7.5 mL (1 1/2 tsp) 48-59 6-8 10 mL (2 tsp) 60-71 9-10 12.5 mL (2 1/2 tsp) 72-95 11 15 mL (3 tsp)
*or as directed by a doctor

No Recall
Chain Drug Consortium, Llc

Childrens Pain Relief | Chain Drug Consortium, Llc

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 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 * or as directed by a doctor Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL
36-47
4-5 years
7.5 mL
48-59
6-8 years
10 mL
60-71
9-10 years
12.5 mL
72-95
11 years
15 mL

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

No Recall
Chain Drug Consortium, Llc

Childrens Pain Relief | Gojo Industries, Inc.

• Wet hands

• Apply a small amount of product and work into a lather

• Rinse well and dry hands completely

No Recall
Chain Drug Consortium, Llc

Childrens Pain Relief | Chain Drug Consortium, Llc

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 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 * or as directed by a doctor Weight (lb)
Age (yr)
Dose (mL)*
under 24
under 2 years
ask a doctor
24-35
2-3 years
5 mL
36-47
4-5 years
7.5 mL
48-59
6-8 years
10 mL
60-71
9-10 years
12.5 mL
72-95
11 years
15 mL

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

No Recall
Allegiant Health

Childrens Pain Relief | Allegiant Health

this product does not contain directions or complete warnings for adult usechew tablets before swallowing all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period follow the chart below for proper dosing or as directed by a doctor if possible, use weight for dosing, otherwise use age

Weight (lbs)

Under 24

24-35

36-47

48-59

60-71

72-95

Age (yrs)

Under 2

2-3

4-5

6-8

9-10

11

Tablets

Consult a doctor

2

3

4

5

6

No Recall
Bio-pharm, Inc.

Childrens 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 use enclosed dosing cup only if possible, use weight to dose; otherwise, use age do not use more than 5 times in 24 hour Weight Age Dose under 24 lbs under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 1 TSP 36 to 47 lbs 4 to 5 years 1 1/2 TSP 48 to 59 lbs 6 to 8 years 2 TSP 60 to 71 lbs 9 to 10 years 2 1/2 TSP 72 to 95 lbs 11 years 3 TSP

No Recall
Quality Choice (Chain Drug Marketing Association)

Childrens Pain Relief | Citron Pharma Llc

Escitalopram tablets should be administered once daily, in the morning or evening, with or without food.
2.1 Major Depressive Disorder
Initial Treatment

Adolescents

The recommended dose of escitalopram tablets is 10 mg once daily. A flexible-dose trial of escitalopram tablets (10 to 20 mg/day) demonstrated the effectiveness of escitalopram tablets [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of three weeks.

Adults

The recommended dose of escitalopram tablets is 10 mg once daily. A fixed-dose trial of escitalopram tablets demonstrated the effectiveness of both 10 mg and 20 mg of escitalopram tablets, but failed to demonstrate a greater benefit of 20 mg over 10 mg [see Clinical Studies (14.1)]. If the dose is increased to 20 mg, this should occur after a minimum of one week.

Maintenance Treatment

It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of continuing escitalopram tablets 10 or 20 mg/day in adults patients with major depressive disorder who responded while taking escitalopram tablets during an 8-week, acute-treatment phase demonstrated a benefit of such maintenance treatment [see Clinical Studies (14.1)]. Nevertheless, the physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Patients should be periodically reassessed to determine the need for maintenance treatment.
2.2 Generalized Anxiety Disorder
Initial Treatment

Adults

The recommended starting dose of escitalopram tablets is 10 mg once daily. If the dose is increased to 20 mg, this should occur after a minimum of one week.

Maintenance Treatment

Generalized anxiety disorder is recognized as a chronic condition. The efficacy of escitalopram tablets in the treatment of GAD beyond 8 weeks has not been systematically studied. The physician who elects to use escitalopram tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2.3 Special Populations
10 mg/day is the recommended dose for most elderly patients and patients with hepatic impairment.

No dosage adjustment is necessary for patients with mild or moderate renal impairment. Escitalopram tablets should be used with caution in patients with severe renal impairment.
2.4 Discontinuation of Treatment with Escitalopram Tablets
Symptoms associated with discontinuation of escitalopram tablets and other SSRIs and SNRIs have been reported [see Warnings and Precautions (5.3)]. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
2.5 Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders
At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with escitalopram tablets. Conversely, at least 14 days should be allowed after stopping escitalopram tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.6 Use of Escitalopram Tablets with Other MAOIs such as Linezolid or Methylene Blue
Do not start escitalopram tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].

In some cases, a patient already receiving escitalopram tablets therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, escitalopram tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with escitalopram tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with escitalopram tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].

No Recall
Chain Drug Consortium (Premier Value)

Childrens Pain Relief | Chain Drug Consortium (premier Value)

this product does not contain directions or complete warnings for adult use shake well before using find right dose on chart below. 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 tsp = teaspoon, mL = milliliter if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor Weight (lb) Age (yr) Dose (tsp or mL) under 24 under 2 ask a doctor 24-35 2-3 1 tsp or 5 mL 36-47 4-5 1½ tsps or 7.5 mL 48-59 6-8 2 tsps or 10 mL 60-71 9-10 2½ tsps or 12.5 mL 72-95 11 3 tsps or 15 mL

No Recall
Chain Drug Consortium (Premier Value)

Childrens Pain Relief | Wal-mart Stores, Inc

shake well for maximum dandruff control, use every time you shampoo wet hair, massage onto scalp, rinse, repeat if desired for best results use at least twice a week or as directed by a doctor

No Recall
Chain Drug Consortium (Premier Value)

Childrens Pain Relief | Direct Rx

Lansoprazole is available as a capsule in 15 mg and 30 mg strengths. Direction for use specific to the route and available methods of administration of this dosage form is presented below. Lansoprazole should be taken before eating. Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole.

2.1 Recommended Dose
*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.†Controlled studies did not extend beyond indicated duration.‡For patients who do not heal with lansoprazole for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole may be considered.§The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.¶Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with lansoprazole for more than 4 years. Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to
Reduce the Risk of
Duodenal Ulcer  Recurrence* Triple Therapy:       Lansoprazole   30 mg Twice daily (q12h) for 10 or 14 days      Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days      Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy:       Lansoprazole   30 mg Three times daily (q8h) for 14 days      Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer      Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated  Gastric Ulcer       Healing 30 mg Once daily for 8 weeks†       Risk Reduction 15 mg Once daily for up to 12 weeks† Gastroesophageal Reflux Disease (GERD)    Short-Term Treatment                                                                                                                              of Symptomatic GERD 15 mg Once daily for up to 8 weeks       Short-Term
Treatment of Erosive     Esophagitis 30 mg Once daily for up to 8 weeks‡ Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis      ≤ 30 kg 15 mg Once daily for up to 12 weeks§      > 30 kg 30 mg Once daily for up to 12 weeks§ (12 to 17 year of age) Short-Term Treatment of Symptomatic GERD      Nonerosive GERD 15 mg Once daily for  up to 8 weeks      Erosive Esophagitis 30 mg Once daily for  up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome 60 mg Once daily¶
Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

2.2 Special Populations

Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see USE IN SPECIFIC POPULATIONS (8.5, 8.6 and 8.7)].

2.3 Important Administration Information

Administration Option

Lansoprazole Delayed-release Capsules – Oral Administration
Lansoprazole delayed-release capsules should be swallowed whole. Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows:
      о   Open capsule.

      о   Sprinkle intact granules on one tablespoon of either applesauce, ENSURE     pudding, cottage cheese, yogurt or strained pears.

      о   Swallow immediately.
Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
      о   Open capsule.

      о   Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).

      о   Mix briefly.

      о   Swallow immediately.

      о   To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

Lansoprazole delayed-release capsules - Nasogastric Tube (≥ 16 French) Administration
For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows:
      о   Open capsule.

      о   Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.

      о   Inject through the nasogastric tube into the stomach.

      о   Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

No Recall
Cardinal Health

Childrens Pain Relief | Cardinal Health

this product does not contain directions or complete warning for adult use find the right dose on chart. If possible, use weight to dose; otherwise, use age. dissolve in mouth or chew before swallowing 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) Tablets under 24 under 2 Ask a doctor 24-35 2-3 2 36-47 4-5 3 48-59 6-8 4 60-71 9-10 5 72-95 11 6

No Recall
Dolgencorp, Llc

Childrens Pain Relief | Specialty Gases Of America

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Great Lakes Wholesale, Marketing, & Sales, Inc.

Childrens Pain Relief | Great Lakes Wholesale, Marketing, & Sales, Inc.

this product does not contain directions or complete warnings for adult use find the right dose on chart. If possible, use weight to dose; otherwise, use age. dissolve in mouth or chew before swallowing 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) Tablets Under 24 Under 2 Ask a doctor 24-35 2-3 2 36-47 4-5 3 48-59 6-8 4 60-71 9-10 5 72-95 11 6

No Recall
Major Pharmaceuticals

Childrens Pain Relief | Major Pharmaceuticals

this product does not contain directions or complete warnings for adult use find the right dose on chart. If possible, use weight to dose; otherwise, use age. dissolve in mouth or chew before swallowing 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) Tablets Under 24 Under 2 Ask a doctor 24-35 2-3 2 36-47 4-5 3 48-59 6-8 4 60-71 9-10 5 72-95 11 6

No Recall
Meijer

Childrens Pain Relief | Meijer

do not use more than directed
(see overdose warning) adults and children 12 years and over: take 2 gelcaps every 6 hours. Do not take more than 8 gelcaps in 24 hours. children under 12 years: do not use htis adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Shopko Stores Operating Co., Llc

Childrens Pain Relief | The Wellness Center For Research And Education

5 drops orally, 2 to 3 times per day. Take for 5 days, stop for 2 days, then repeat until you see symptoms abate. Consult a physician for use in children under 12 years of age.

No Recall
Western Family Foods Inc

Childrens 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. 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 1/2 tsp)

48-59

6-8 years

10 mL (2 tsp)

60-71

9-10 years

12.5 mL (2 1/2 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
Cvs Pharmacy

Childrens Pain Relief | Cvs Pharmacy

• 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

Childrens Pain Relief | Rare Disease Theraputics, Inc

For Intravenous use only.

Administer Anavip as soon as possible after rattlesnake bite in patients who develop any signs of envenomation (e.g., local injury, coagulation abnormality, or systemic signs of envenomation).

The amount of antivenin required to treat a snake bitten patient is highly variable owing in part to the venom burden, the potency of the venom and the time to health care presentation. Use supportive measures to treat certain manifestations of rattlesnake envenomation, such as pain, swelling, hypotension, and wound infection. Contact the local poison control centers for additional individual treatment advice.

Prior to initiating treatment perform laboratory analyses, including complete blood count, platelet count, PT, PTT, serum fibrinogen level and routine serum chemistries. Repeat testing at regular intervals to gauge response to therapy and anticipate additional dosing.

Initial Dose: 10 vials
The initial dose of Anavip is 10 vials. Reconstitute the contents of each vial with 10 milliliters (mL) of sterile normal saline. Reconstitution time should be less than one minute when using continuous gentle swirling. Inspect the solution visually for particulate matter and discoloration prior to administration. The solution is expected to be clear to yellow/green and opalescent. Do not use if otherwise discolored or turbid. Combine the contents of the reconstituted vials promptly and further dilute to a total volume of 250 mL with sterile normal saline. Fluid volumes may need to be adjusted for very small children or infants. Poison Control Centers are a helpful resource for individual treatment advice. Infuse intravenously over 60 minutes. For the first 10 minutes infuse at a 25-50 mL/hour rate, carefully monitoring for any allergic reactions, including an anaphylactic reactions. Discontinue the infusion if any allergic reaction occurs and institute appropriate emergency treatment. Reassess the risk to benefit before continuing the infusion. If no reactions occur, the infusion rate may be increased to the full 250 mL/hour rate until completion. If there is any allergic reaction at any time, stop the infusion, treat accordingly, and reassess the need to continue Anavip. Following the completion of infusion, monitor the patient for at least 60 minutes for any allergic reaction and to determine that local signs of envenomation are not progressing (leading edge of local injury not progressing), systemic symptoms are resolved and coagulation parameters have normalized or are trending toward normal. Discard partially or unused reconstituted and diluted product.
Additional Dosing to Achieve Initial Control
Administer additional 10 vial doses if needed to arrest the progressive symptoms and repeat every hour. There is no known maximum dose. Repeat above steps for initial dose as many times as needed until local signs of envenomation are not progressing, systemic symptoms are resolved and coagulation parameters have normalized or are trending toward normal. Prepare as described above for initial dose. Once initial control has been achieved, observe the patient to determine any need for further dosing, as described below.
Observation and late Dosing
Monitor patients in a health care setting at least 18 hours following initial control of signs and symptoms. Re-emerging symptoms including coagulopathies may be suppressed with additional 4 vial doses of Anavip as needed. Reconstitute each vial with 10 mL of sterile normal saline. Combine and further dilute to a total of 250 mL. Infuse intravenously over 60 minutes. 3 DOSAGE FORMS AND STRENGTHS
Anavip is supplied as a sterile, lyophilized powder. Each vial contains not more than 120 milligrams (mg) total protein and not less than the indicated number of mouse LD50 neutralizing units:

Snake Species Used for Standardization Minimum Mouse LD50 Units per Vial Bothrops asper 780 Crotalus durissus 790 4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity
Anavip may cause allergic reactions.
Patients with known allergies to horse protein are particularly at risk for an anaphylactic reaction. If signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypertension) occur, discontinue immediately and institute appropriate treatment. Monitor patients with follow-up visits for signs and symptoms of delayed allergic reactions or serum sickness (rash, fever, myalgia, arthralgia, pruritus, urticarial rash) and treat appropriately if necessary. 5.2 Transmissible Infectious Agents
Anavip is made from equine (horse) plasma and may therefore carry a risk of transmitting infectious agents, e.g., viruses.
5.3 Reactions to Cresol
Trace amounts of cresol from the manufacturing process are contained in Anavip. Localized reactions and generalized myalgias have been reported with the use of cresol as an injectable excipient.
6 ADVERSE REACTIONS
The most common adverse reactions observed in more than 2 percent of patients in the clinical trials for Anavip were: pruritus, nausea, rash, arthralgia, peripheral edema, erythema, headache, myalgia, pain in extremity, and vomiting.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

A total of 86 patients were treated with Anavip, ranging from 2 to 80 years old. The patient population was comprised of 60 males and 26 females. Patients were monitored for signs and symptoms of adverse reactions, including acute hypersensitivity reactions and serum sickness. Follow-up interviews were conducted at 5, 8, 15 and 22 days after treatment to assess symptoms of ongoing venom effect, serum sickness, and any other adverse reactions.

Table 1 shows the adverse reactions occurring in patients across all clinical trials for Anavip. Seventy six percent (65/86) of patients receiving Anavip reported at least one adverse reaction.
Table 1: Incidence of Adverse Events in Clinical Studies of Anavip by Body System Anavip [N=86]
n (%) Patients Reporting at Least One Adverse Event 65 (76%) Skin and subcutaneous tissue disorders 47 (55%) Pruritus 37 (43%) Rash 10 (12%) Blister 4 (5%) Erythema 3 (4%) Gastrointestinal disorders 28 (33%) Nausea 20 (23%) Vomiting 5 (6%) Musculoskeletal and connective tissue disorders 19 (22%) Arthralgia 9 (11%) Myalgia 6 (7%) Pain in extremity 5 (6%) General disorders and administration site conditions 21 (24%) Edema peripheral 7 (8%) Chills 3 (4%) Pyrexia 4 (5%) Nervous system disorders 12 (14%) Headache 5 (6%) Phychiatric disorders 4 (5%) Anxiety 2 (2%) Insomnia 2 (2%) Metabolism and nutrition disorders 4 (5%) Dehydration 2 (2%) Respiratory, thoracic and mediastinal disorders 5 (6%) Dyspnea 1 (1%) Blood and lymphatic system disorders 2 (2%) Thrombocytopenia 1 (1%) 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy
Pregnancy Category C: Animal reproduction studies have not been conducted with Anavip. It is also not known whether Anavip can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Anavip should be given to a pregnant woman only if clearly needed.
8.3 Nursing Mothers
It is not known whether Anavip is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Anavip is administered to a nursing woman.
8.4 Pediatric Use
Twenty-four percent (21/86) of patients studied in clinical trials were 16 years of age or younger (6 patients were 2 years of age to 5 years of age, 15 patients ranged from at least 5 years of age to 16 years of age). None of the pediatric patients in the phase 3 study experienced a recurrent coagulopathic effect. All adverse reactions in the pediatric patients were non-serious. The most frequent adverse reactions among pediatric patients were nausea and vomiting, itching and fever. Thus, the safety and efficacy in the pediatric population was not different from adults.
8.5 Geriatric Use
Over 9 percent (8/86) of patients studied in clinical trials were over 65 years of age. The efficacy of Anavip in the geriatric population appears comparable to the overall population.

No Recall
Walgreen Co.

Childrens Pain Relief | Walgreen Co.

do not give more than directed (see overdose warning) this product does not contain directions or complete warnings for adult use find the right dose on chart below. If possible, use weight to dose; otherwise, use age. chew before swallowing; this product will soften in mouth for ease of chewing 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 (tablets)* Under 24 Under 2 Ask a doctor 24-35 2-3 2 36-47 4-5 3 48-59 6-8 4 60-71 9-10 5 72-95 11 6
*or as directed by a doctor

No Recall