Active Ingredient
Chlorpheniramine Maleate 4 mg
Allergy Tablet
FDA Label NDC 69168-277
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Allergy (NDC 69168-277). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor or pharmacist before use if you, when using this product, if pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antihistamine
Uses
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat
Warnings
Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis, glaucoma or trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You
are taking sedatives or tranquilizers
When Using This Product
marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga motor vehicle or operating machinery
excitability may occur especially in children
If Pregnant Or Breast-Feeding
ask a health professional before use
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately
Directions
take every 4 to 6 hours do not take more than 6 doses in 24 hours Adults and children 12 years
and over: 1 tablet Children 6 to under 12 years: 1/2 tablet Children under 6 years: consult a doctor
Inactive Ingredients
D.&C. Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.
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