Active Ingredient (In Each Tablet)
Chlorpheniramine maleate 4 mg
Allergy
FDA Label NDC 33261-222
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidarex Pharmaceuticals Llc for the product Allergy (NDC 33261-222). 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, 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,, 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
Use
- 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
Ask A Doctor Before Use If You Have
- glaucoma
- a breathing problem such as emphysema or chronic bronchitis
- 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 right away.
Directions
| adults and children 12 years of age and older | 1 tablet every 4 to 6 hours. Do not take more than 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. Do not exceed 3 tablets in 24 hours. |
| children under 6 years of age | do not use this product in children under 6 years of age |
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
NDC 33261-0222-30
Allergy
Tablets
Antihistamine
RELIEVES: Sneezing,
Itchy, Watery Eyes,
Itchy Throat, Runny Nose
*Compare to the active ingredient in Chlor-Trimeton® Allergy Tablets
Chlorpheniramine maleate 4 mg EACH
4 hour
24 TABLETS
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Chlor-Trimeton® Allergy Tablets.
50844 REV0512K19408
Distributed by Major Pharmaceuticals
31778 Enterprise Drive
Livonia, MI 48150 USA
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880
REV. 05/12
M-17
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
Image Label (Chlorpheniramine Male 4mg Tab For Major 1) 
* Please review the disclaimer below.
