Alavert Allergy and Congestion D-12 hour

LORATADINE AND PSEUDOEPHEDRINE SULFATE ORAL HUMAN OTC DRUG

Alavert Allergy and Congestion D-12 hour is an FDA drug label for the active ingredient LORATADINE AND PSEUDOEPHEDRINE SULFATE manufactured by Foundation Consumer Brands administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20211207.

Generic name
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Manufacturer
Foundation Consumer Brands
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
80070-100
Application
ANDA076050
Label effective
20211207

Active ingredients

Active ingredients (in each tablet) Purposes Loratadine 5 mg Antihistamine Pseudoephedrine sulfate 120 mg Nasal decongestant

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

Dosage & Administration

Directions do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Contraindications

Not available.

Warnings

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs 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).

Adverse Reactions

Not available.

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