Active Ingredient
Chlorpheniramine Maleate 4 mg
Allergy Tablet, Coated
FDA Label NDC 68998-277
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Marc Glassman, Inc. for the product Allergy (NDC 68998-277). 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, ask a doctor before use if you have, ask a doctor or pharmacist before use if you, when using this product, pregnancy/breastfeeding, 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
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
Pregnancy/Breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
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
Other Information
■ Store at room temperature in a dry place
Inactive Ingredients
D&C Yellow #10 lake, lactose, magnesium stearate, microcrystalline cellulose, stearic acid. May contain starch.
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