Active Ingredient (In Each Tablet)
Chlorpheniramine maleate 4 mg
Allergy Tablet
FDA Label NDC 37835-633
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Allergy (NDC 37835-633). 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 (in each tablet), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, if pregnant or breast-feeding,, 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 the following symptoms due to hay fever and other upper respiratory allergies:
- sneezing
- itchy, watery eyes
- runny nose
- itching of the nose and throat
Warnings
Do not use to make a child sleepy.
Ask A Doctor Before Use If You Have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- avoid alcoholic drinks
- drowsiness may occur
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
- 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, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
| adults and children 12 years of age 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 | ask a doctor |
Other Information
- store at 15 o-25 oC (59 o-77 oF)
- protect from moisture
Inactive Ingredients
corn starch, croscarmellose sodium, D&C yellow # 10 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide.
Questions?
call toll free 1-844-912-4012
Principal Display Panel
Label (Label 100ct) 
* Please review the disclaimer below.
