Active Ingredient (In Each Tablet)
Chlorpheniramine maleate 4 mg
Allergy
FDA Label NDC 68788-6951
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Preferred Pharmaceuticals Inc. for the product Allergy (NDC 68788-6951). 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, do not use, 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 these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
Do Not Use
to make a child sleepy.
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
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a 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 overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
adults and children | 1 tablet every 4 to 6 |
children 6 to under | 1/2 tablet (break tablet in |
children under 6 | do not use this product in |
Other Information
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from excessive moisture
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose
Questions Or Comments?
(800) 616-2471
Principal Display Panel
MAJOR®
NDC 68788-6951-02
*Compare to the active ingredient in
Chlor-Trimeton® Allergy Tablets
Allergy
Tablets
Chlorpheniramine maleate 4 mg EACH
ANTIHISTAMINE
Relieves:
• Sneezing • Itchy, Watery Eyes
• Itchy Throat • Runny Nose
4 hour
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*This product is not manufactured or distributed by
MSD Consumer Care, Inc., owner of the registered
trademark Chlor-Trimeton® Allergy Tablets.
50844 REV0213L19412
Distributed by MAJOR® PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA
Rev. 12/14 Re-order No. 700459 M-17
Repackaged By: Preferred Pharmaceuticals Inc.
X:\i4i\label Scans\chlorpheniramine Maleate Tablets 4mg, Major.jpg (Major 44 194 1)
* Please review the disclaimer below.
