Nasal Decongestant

Nasal Decongestant Recall

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Questions & Answers

Side Effects & Adverse Reactions

Ask a doctor before use if you have • diabetes • high blood pressure • heart disease • thyroid disease • trouble urinating due to an enlarged prostate gland

When using this product • do not use more than directed

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with fever

If pregnant or breast-feeding, • ask a health professional before use.

Keep out of reach of children. • In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do not use • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or 2 weeks after stoppin the MAOI drug. If you do not know if your prescription drug contains and MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • diabetes • high blood pressure • heart disease • thyroid disease • trouble urinating due to an enlarged prostate gland Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or occur with fever

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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 relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose

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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

Nasal Decongestant Manufacturers

Proficient Rx Lp

Nasal Decongestant | Proficient Rx Lp

adults and children
12 years and older
take 2 tablets every 4 to 6 hours;
do not take more than 8 tablets in
24 hours
children ages 6 to 12 years
take 1 tablet every 4 to 6 hours;
do not take more than 4 tablets in
24 hours
children under 6 years
do not use

No Recall
Supervalu Inc.

Nasal Decongestant | Supervalu Inc.

adults and children
12 years and older take 2 tablets every 4 to 6 hours;
do not take more than 8 tablets in
24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours;
do not take more than 4 tablets in
24 hours children under 6 years do not use this product in children
under 6 years of age

No Recall
Rugby Laboratories, Inc

Nasal Decongestant | Rugby Laboratories, Inc

Directions
take every 4-6 hours do not take more than 4 doses in 24 hours adults and children 12 years and over: 2 tablets
children 6 to under 12 years: 1 tablet
children under 6 years: do not use

No Recall
Publix Super Markets Inc

Nasal Decongestant | Publix Super Markets Inc

adults and children 12 years and over take 2 tablets every 4 to 6 hours do not take more than 8 tablets in 24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours do not take more than 4 tablets in 24 hours children under 6 years do not use this product in children under 6 years of age

No Recall
Publix Super Markets Inc

Nasal Decongestant | Publix Super Markets Inc

adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

No Recall
Hyvee Inc

Nasal Decongestant | Hyvee Inc

adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

No Recall
Navarro Discount Pharmacies,llc

Nasal Decongestant | Navarro Discount Pharmacies,llc

To spray, squeeze bottle qiuckly and firmly Do not tilt head backward while spraying Wipe nozzle clean after use Do not exceed 2 doses in any 24 hour period adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours chlidren under 6 years of age: ask a doctor

No Recall
Bryant Ranch Prepack

Nasal Decongestant | Bryant Ranch Prepack

Directions
take every 4-6 hours do not take more than 4 doses in 24 hours adults and children 12 years and over: 2 tablets
children 6 to under 12 years: 1 tablet
children under 6 years: do not use

No Recall
Rebel Distributors Corp

Nasal Decongestant | Rebel Distributors Corp

adults and children 12 years and over take 1 tablet every 12 hours do not take more than 2 tablets in 24 hours children under 12 years do not use this product in children under 12 years of age

No Recall
Kareway Product, Inc.

Nasal Decongestant | Kareway Product, Inc.

Shake well before use. To spray, remove the clear plastic cap. Hold bottle with thumb at base and nozzle between first and second fingers. If this is the first time you are using the pump, spray several times into the air until you get a fine mist. If you have not used the pump for 14 days, spray several times into the air before using again. Insert nozzle into nostril. Spray upward while breathing in through the nose. Repeat in other nostril. Wipe nozzle clean after use. Put clear plastic cap back on the bottle Do not exceed 2 doses in any 24 hour period. adults and children 6 to under 12 years of age (with adult supervision) 2 or 3 spray in each nostril not more often than every 10 to 12 hours children under 6 years of age ask a doctor

No Recall
Rugby Laboratories

Nasal Decongestant | Rugby Laboratories

adults and children
12 years and older take 2 tablets every 4 to 6 hours;
do not take more than 8 tablets in
24 hours children ages 6 to 12 years take 1 tablet every 4 to 6 hours;
do not take more than 4 tablets in
24 hours children under 6 years do not use

No Recall
L.n.k. International, Inc.

Nasal Decongestant | Mylan Pharmaceuticals Inc.

2.1 Required Laboratory Testing Prior to Initiation and During Therapy
Prior to initiating treatment with clozapine orally disintegrating tablets, a baseline ANC must be obtained. The baseline ANC must be at least 1500/μL for the general population, and at least 1000/μL for patients with documented Benign Ethnic Neutropenia (BEN). To continue treatment, the ANC must be monitored regularly [see Warnings and Precautions (5.1)].
2.2 Important Administration Instructions
Clozapine orally disintegrating tablets should be immediately placed in the mouth after removing the tablet from the blister pack or bottle. The tablet disintegrates rapidly after placement in the mouth. The tablets can be allowed to disintegrate, or they may be chewed. They may be swallowed with saliva. No water is necessary for administration.
The orally disintegrating tablets in a blister pack should be left in the unopened blister until the time of use. Just prior to use, peel the foil from the blister and gently remove the orally disintegrating tablet. Do not push the tablets through the foil, because this could damage the tablet.
2.3 Dosing Information
The starting dose is 12.5 mg once daily or twice daily. The total daily dose can be increased in increments of 25 mg to 50 mg per day, if well-tolerated, to achieve a target dose of 300 mg to 450 mg per day (administered in divided doses) by the end of 2 weeks. Subsequently, the dose can be increased once weekly or twice weekly, in increments of up to 100 mg. The maximum dose is 900 mg per day. To minimize the risk of orthostatic hypotension, bradycardia, and syncope, it is necessary to use this low starting dose, gradual titration schedule, and divided dosages [see Warnings and Precautions (5.3)].
Clozapine orally disintegrating tablets can be taken with or without food [see Pharmacokinetics (12.3)].
2.4 Maintenance Treatment
Generally, patients responding to clozapine orally disintegrating tablets should continue maintenance treatment on their effective dose beyond the acute episode.
2.5 Discontinuation of Treatment
Method of treatment discontinuation will vary depending on the patient’s last ANC:
• See Tables 2 or 3 for appropriate ANC monitoring based on the level of neutropenia if abrupt treatment discontinuation is necessary because of moderate to severe neutropenia. • Reduce the dose gradually over a period of 1 to 2 weeks if termination of clozapine orally disintegrating tablets therapy is planned and there is no evidence of moderate to severe neutropenia. • For abrupt clozapine discontinuation for a reason unrelated to neutropenia, continuation of the existing ANC monitoring is recommended for general population patients until their ANC is ≥ 1500/μL and for BEN patients until their ANC is ≥ 1000/μL or above their baseline. • Additional ANC monitoring is required for any patient reporting onset of fever (temperature of 38.5°C or 101.3°F, or greater) during the 2 weeks after discontinuation [see Warnings and Precautions (5.1)]. • Monitor all patients carefully for the recurrence of psychotic symptoms and symptoms related to cholinergic rebound such as profuse sweating, headache, nausea, vomiting, and diarrhea. 2.6 Re-Initiation of Treatment
When restarting clozapine orally disintegrating tablets in patients who have discontinued clozapine orally disintegrating tablets (i.e., 2 days or more since the last dose), re-initiate with 12.5 mg once daily or twice daily. This is necessary to minimize the risk of hypotension, bradycardia, and syncope [see Warnings and Precautions (5.3)].If that dose is well-tolerated, the dose may be increased to the previously therapeutic dose more quickly than recommended for initial treatment.
2.7 Dosage Adjustments with Concomitant Use of CYP1A2, CYP2D6, CYP3A4 Inhibitors or CYP1A2, CYP3A4 Inducers
Dose adjustments may be necessary in patients with concomitant use of: strong CYP1A2 inhibitors (e.g., fluvoxamine, ciprofloxacin, or enoxacin); moderate or weak CYP1A2 inhibitors (e.g., oral contraceptives, or caffeine); CYP2D6 or CYP3A4 inhibitors (e.g., cimetidine, escitalopram, erythromycin, paroxetine, bupropion, fluoxetine, quinidine, duloxetine, terbinafine, or sertraline); CYP3A4 inducers (e.g., phenytoin, carbamazepine, St. John’s wort, and rifampin); or CYP1A2 inducers (e.g., tobacco smoking) (Table 1) [see Drug Interactions (7)].
Table 1: Dose Adjustments in Patients Taking Concomitant Medications
Co-medications
Scenarios
Initiating clozapine orally disintegrating tablets while taking a co-medication
Adding a co-medication while taking clozapine orally disintegrating tablets
Discontinuing a co-medication while continuing clozapine orally disintegrating tablets
Strong CYP1A2 Inhibitors
Use one-third of the clozapine orally disintegrating tablets dose.
Increase clozapine orally disintegrating tablets dose based on clinical response.
Moderate or Weak CYP1A2 Inhibitors
Monitor for adverse reactions. Consider reducing the clozapine orally disintegrating tablets dose if necessary.
Monitor for lack of effectiveness. Consider increasing clozapine orally disintegrating tablets dose if necessary.
CYP2D6 or CYP3A4 Inhibitors
Strong CYP3A4 Inducers
Concomitant use is not recommended. However, if the inducer is necessary, it may be necessary to increase the clozapine orally disintegrating tablets dose. Monitor for decreased effectiveness.
Reduce clozapine orally disintegrating tablets dose based on clinical response.
Moderate or Weak CYP1A2 or CYP3A4 Inducers
Monitor for decreased effectiveness. Consider increasing the clozapine orally disintegrating tablets dose if necessary.
Monitor for adverse reactions. Consider reducing the clozapine orally disintegrating tablets dose if necessary.
2.8 Renal or Hepatic Impairment or CYP2D6 Poor Metabolizers
It may be necessary to reduce the clozapine orally disintegrating tablets dose in patients with significant renal or hepatic impairment, or in CYP2D6 poor metabolizers [see Use in Specific Populations (8.6, 8.7)].

No Recall
Save-a-lot Food Stores, Ltd.

Nasal Decongestant | Save-a-lot Food Stores, Ltd.

adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours.
children under 12 years: do not use this product in children under 12 years of age

No Recall
Shopko Stores Operating Co., Llc

Nasal Decongestant | Synergy Formulas, Inc.

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

No Recall
Promex, Llc

Nasal Decongestant | Promex, Llc

To spray, squeeze bottle qiuckly and firmly Do not tilt head backward while spraying Wipe nozzle clean after use Do not exceed 2 doses in any 24 hour period adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours chlidren under 6 years of age: ask a doctor

No Recall
L Perrigo Company

Nasal Decongestant | L Perrigo Company

adults and children 12 years and over
• take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours
children ages 6 to 12 years
• take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours
children under 6 years
do not use this product in children under 6 years of age

No Recall
Premier Value (Chain Drug Consortium, Llc)

Nasal Decongestant | Chain Drug Consortium, Llc

do not exceed recommended dosage drink a full glass of water with each dose adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours, unless directed by a doctor children under 12 years of age: consult a doctor

No Recall
Safeway

Nasal Decongestant | Safeway

• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctor
To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

No Recall
Cvs Pharmacy

Nasal Decongestant | H E B

• take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over
30 mL (2 TBSP) every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use

No Recall
Shopko Stores Operating Co., Llc

Nasal Decongestant | Laboratoires Clarins S.a.

apply liberally 15 minutes before sun exposure. apply to all skin exposed to the sun. children under 6 months: Ask a doctor. Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses. reapply at least every 2 hours. use a water resistant sunscreen if swimming or sweating.

No Recall
Kroger Company

Nasal Decongestant | Kroger Company

adults and children 12 years and over
• take 2 tablets every 4 to 6 hours • do not take more than 8 tablets in 24 hours
children ages 6 to 12 years
• take 1 tablet every 4 to 6 hours • do not take more than 4 tablets in 24 hours
children under 6 years
do not use this product in children under 6 years of age

No Recall
Safeway

Nasal Decongestant | Safeway

• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctor
To spray, squeeze bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

No Recall
Safeway

Nasal Decongestant | Safeway

• adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. • children under 6 years of age: ask a doctor
Shake well before use. Before using the first time, remove the protective cap from the tip and prime metered pump by depressing pump firmly several times. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after use.

No Recall
H E B

Nasal Decongestant | Impax Generics

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF DOXYCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
Adults
The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours or 50 mg every 6 hours) followed by a maintenance dose of 100 mg/day. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For pediatric patients above eight years of age
The recommended dosage schedule for pediatric patients weighing 100 pounds or less is 2 mg/lb of body weight divided into two doses on the first day of treatment, followed by 1 mg/lb of body weight given as a single daily dose or divided into two doses, on subsequent days. For more severe infections up to 2 mg/lb of body weight may be used. For pediatric patients over 100 pounds the usual adult dose should be used.
Uncomplicated gonococcal infections in adults (except anorectal infections in men)
100 mg, by mouth, twice a day for 7 days. As an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose.
Acute epididymo-orchitis caused by N. gonorrhoeae
100 mg, by mouth, twice a day for at least 10 days.
Primary and secondary syphilis
300 mg a day in divided doses for at least 10 days.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis
100 mg, by mouth, twice a day for at least 7 days.
Nongonococcal urethritis caused by C. trachomatis and U. urealyticum
100 mg, by mouth, twice a day for at least 7 days.
Acute epididymo-orchitis caused by C. trachomatis
100 mg, by mouth, twice a day for at least 10 days.
Inhalational anthrax (post-exposure)
ADULTS: 100 mg of doxycycline, by mouth, twice a day for 60 days. CHILDREN: weighing less than 100 pounds (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice a day for 60 days. Children weighing 100 pounds or more should receive the adult dose.
When used in streptococcal infections, therapy should be continued for 10 days.
Administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration. (See ADVERSE REACTIONS.) If gastric irritation occurs, doxycycline may be given with food. Ingestion of a high fat meal has been shown to delay the time to peak plasma concentrations by an average of one hour and 20 minutes. However, in the same study, food enhanced the average peak concentration by 7.5% and the area under the curve by 5.7%.

No Recall