Active Ingredient (In Each Capsule)
Diphenhydramine HCl 50 mg
Allergy Relief Capsule, Liquid Filled
FDA Label NDC 69452-452
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 69452-452). 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, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use, when using this product, 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 ■ itching of the nose or throat ■ itchy, watery eyes
Warnings
■ May cause excitability especially in children.
■ May cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect.
Do Not Use
■ for children under 12 years of age ■ with any other product containing diphenhydramine, even one used on skin.
Ask A Doctor Before Use If You Have
■ glaucoma ■ difficulty in urination due to enlargement of the prostate gland
■ a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use
if you are taking sedatives or tranquilizers.
When Using This Product
■ avoid alcoholic beverages ■ be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 weeks
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.
Directions
| adults and children 12 years and over | ■ take 1 capsule every 4 to 6 hours, or as directed by a doctor
■ do not take more than 6 capsules in 24 hours |
| children under 12 years | do not use |
Other Information
■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F).
■ protect from light
Inactive Ingredients
gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution
Questions Or Comments?
call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
Other
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
†This product is not manufactured or distributed by the owners of Benadryl® Allergy Extra Strength.
Manufactured for:
Bionpharma
Princeton, NJ 08540
Mfg. Lic. No.: TN00002123
L0000864
R0524
2122631
100'S Count
†Compare to the active ingredient in Benadryl® Allergy Extra Strength
NDC 69452-452-20
a+ health TM
dye-free
extra strength
allergy relief
diphenhydramine HCl capsules USP, 50 mg
antihistamine
• sneezing • runny nose
• itchy, watery eyes • itchy throat or nose
100 softgels **
**liquid-filled capsules
Carton (Carton)
* Please review the disclaimer below.
