Active Ingredient (In Each Capsule)
Diphenhydramine HCl 25 mg
Allergy Relief Tablet
FDA Label NDC 69452-444
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Allergy Relief (NDC 69452-444). 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 capsule), purpose, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use, 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 the other upper respiratory allergies:
■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat
Warnings
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
■ 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
■ marked drowsiness may occur ■ avoid alcoholic drinks ■ alcohol, sedatives, and tranquilizers may increase drowsiness ■ be careful
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 Centre right away. (1-800-222-1222)
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 18 mg ■ store between 20-25°C (68-77°F).
Protect from light and excessive humidity. Exposure to excessive humidity and/or light may cause the color of the tablets to fade.
Inactive Ingredients
carnauba wax, croscarmellose sodium, D&C red no.27, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide
Questions Or Comments?
call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Other
†This product is not manufactured or distributed by the owners of Benadryl® Allergy Tablets
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED
WITH“SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
Manufactured for:
BIONPHARMA INC.
Princeton, NJ 08540
MADE IN INDIA
Code: TN/Drugs/TN00002222/2006
948006874
L0000934
R1224
600'S Count
†Compare to the active ingredient in
Benadryl® Allergy Tablets
NDC 69452-444-31
a+ health
TM
diphenhydramine HCl
tablets, 25 mg
antihistamine
allergy relief
• sneezing
• runny nose
• itchy, watery eyes
• itchy throat or nose
600 tablets
600ct-bottle (600ct Bottle)
* Please review the disclaimer below.
