Otc - Active Ingredient
Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg
Allergy Time Tablet
FDA Label NDC 49483-242
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Time Cap Labs Inc for the product Allergy Time (NDC 49483-242). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Antihistamine
Indications & Usage
Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
runny nose, sneezing, itching of the nose or throat, itch, watery eyes
Warnings
Warnings
Ask a doctor before use if you have:
glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty urinating due to an enlarged prostate gland
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.
Otc - When Using
When using this product:
excitability may occur, especially in children; drowsiness may occur; avoid alcoholic beverages; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding ask a health professional before use.
Dosage & Administration
Directions
Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
Children 6 to under 12 years of age - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
Children under 6 years of age - do not use
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
Package Label.Principal Display Panel
100 Ct Label (242r)
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