Active Ingredient (In Each Tablet)
Diphenhydramine HCl 25 mg
Banophen Tablet, Film Coated
FDA Label NDC 0904-5551
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 Banophen (NDC 0904-5551). 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
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
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
- marked 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
- do not take more than 6 times in 24 hours
| adults and children 12 years and over | 1 to 2 tablets |
| children 6 to under 12 years | 1 tablet |
| children under 6 years | do not use |
Other Information
- each tablet contains: calcium 30 mg
- 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 moisture
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, D&C red #27 aluminum lake, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide
Principal Display Panel
MAJOR®
NDC 0904-5551-24
*Compare to the active ingredient in Benadryl® Allergy ULTRATAB® Tablets*
BANOPHEN™
Diphenhydramine HCl 25 mg
Antihistamine
MINITABS
Complete Allergy Medication
For the temporary relief of the symptoms of:
• Upper Respiratory Allergies • Hay Fever
24 MINITABS
*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl® Allergy ULTRATAB® Tablets.
50844 REV1016L32908
Distributed by MAJOR® PHARMACEUTICALS
17177N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA M-17
Re-order No. 250050
Rev. 01/17
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Major 44-329 (Major 44 329 1)
* Please review the disclaimer below.
