ALLERGY RELIEF- diphenhydramine hcl tablet

Drug Labeling and Warnings

Drug Details [pdf]

Active ingredient (in each capsule)

Diphenhydramine HCl 50 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

■ May cause excitability especially in children.

■ May cause 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 ■ a breathing problem such as emphysema or chronic bronchitis
■ 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

■ avoid alcoholic drinks ■ be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persisits 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 tablet every 4 to 6 hours, or as directed by the doctor

  ■ do not take more than 6 tablets in 24 hours

• children under 12 years: do not use

Other information

■ each tablet contains: calcium 35 mg■ store between 20-25°C (68-77°F). Protect from light.

■ do not use if blister unit is torn or broken

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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 Extra Strength

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND

TAMPER-EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE

WARNINGS AND PRODUCT INFORMATION.

Distributed By

AmerisourceBergen

1 West First Avenue

Conshohocken, PA 19428

Questions or Concerns?

www.mygnp.com

MADE IN INDIA

949129368

Code: TN/Drugs/TN00002222/2006

L0001216

R0126

24's count

Compare to the active ingredient in Benadryl® Allergy Extra Strength†

GOOD

NEIGHBOR

PHARMACY

Extra Strength
Allergy Relief

Diphenhydramine HCl tablets, 50 mg

Antihistamine

sneezing runny nose
itchy, watery eyes itching of the nose or throat

24 tablets

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-829
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
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	white	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	DH50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-829-51	2 in 1 CARTON	05/04/2026
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	05/04/2026

Labeler - AMERISOURCE BERGEN (007914906)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
OrBion Pharmaceuticals Private Limited		854403569	pack(46122-829) , manufacture(46122-829)