Active Ingredient (In Each Tablet)
Chlorpheniramine maleate 4 mg
Allergy Tablet
FDA Label NDC 0904-0012
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Allergy (NDC 0904-0012). 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
- difficulty in urination due to enlargement of the 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
- take every 4 to 6 hours, or as directed by a doctor
| adults and children 12 years and over | 1 tablet. Do not exceed 6 tablets in 24 hours. |
| children 6 to under 12 years | 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. |
| children under 6 years | do not use |
Other Information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- 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 0904-0012-24
4 Hour
Allergy Tablets
Chlorpheniramine Maleate
4 mg
Antihistamine
Relieves:
Sneezing, Runny Nose,
Itchy, Watery Eyes,
Itchy Throat
Actual Size
24 Tablets
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
50844 REV0419ML19408
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Rev. 10/19 M-17 Re-order No. 700790
Major 44-194 (Major 44 194 1)
Principal Display Panel - Unit Dose
NDC 0904-0012-61
MAJOR®
Unit Dose
ALLERGY TABLETS
CHLORPHENIRAMINE MALEATE
Antihistamine
4 mg
100 TABLETS
This Unit Dose package is not child resistant and is Intended for Institutional Use Only.
50844 REV0419B19412
Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152
Rev. 10/19 M-17 Re-order No. 301560
Major 44-194-dsp (Major 44 194 2)
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