ALLERGY RELIEF- diphenhydramine hcl tablet

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by BIONPHARMA INC., Bionpharma Inc., OrBion Pharmaceuticals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

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)

SPL UNCLASSIFIED SECTION

†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

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-444
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	DH25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-444-31	600 in 1 BOTTLE; Type 0: Not a Combination Product	06/24/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	06/24/2025

Labeler - BIONPHARMA INC. (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
OrBion Pharmaceuticals Private Limited		854403569	manufacture(69452-444)