Cold and Allergy

PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE ORAL HUMAN OTC DRUG

Cold and Allergy is an FDA drug label for the active ingredient PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE manufactured by Allegiant Health 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 20191212.

Generic name
PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE
Manufacturer
Allegiant Health
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
69168-406
Application
M012
Label effective
20191212

Active ingredients

Active ingredients (in each tablet) Phenylephrine HCl 10 mg Chlorpheniramine maleate 4mg

Indications & Usage

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

Dosage & Administration

Directions Adults and children 12 years of age and older: 1 tablet every 4 to 6 hours. Do not take more than 6 doses in 24 hours Children under 12 years of age: Consult a doctor

Contraindications

Not available.

Warnings

Warnings Do Not Use if you are now taking a prescription monoamine oxadise 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 a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to an enlarged prostate gland diabetes heart disease high blood pressure thyroid disease Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed may cause excitability, especially in children may cause drowsiness; alcohol, sedatives or tranquilizers may increase drowsiness avoid alcoholic beverages and use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding ask a health professional before use.

Adverse Reactions

Not available.