ALLERGY RELIEF- diphenhydramine hcl capsule, liquid filled

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by BIONPHARMA INC., Bionpharma Inc., SOFTGEL HEALTHCARE 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 ■ 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

■ Do not use for children under 6 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 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 Center right away.

Directions

■ Do not use for children under 6 years of age ■ do not take more than 6 doses in 24 hours

• adults and children 12 years and over: 1 to 2 capsules
• children 6 to under 12 years: 1 capsule
• children under 6 years: do not use this product for children under 6 years of age

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, propylene glycol, purified water, sorbitol sorbitan solution

Questions or comments?

call toll-free 1-888-235-2466(Mon - Fri 9AM - 5PM EST)

SPL UNCLASSIFIED SECTION

THIS PRODUCT IS PACKAGED IN A TAMPER EVIDENT PACKAGE.
USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by the owners of Benadryl® Allergy LIQUI-GELS®

Manufactured for:

BIONPHARMA
Princeton, NJ 08540

MADE IN INDIA

Mfg. Lic. No.: TN00002123

2122718

L0000935

R1124

48's count

NDC: 69452-453-09

†Compare to the active ingredient in Benadryl ®Allergy LIQUI-GELS ®†

a+ health

dye-free

allergy refief

diphenhydramine HCl capsules

USP, 25 mg
antihistamine

48 softgels**

**liquid-filled capsules

sneezing runny nose
itchy, watery eyes itchy throat or nose

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-453
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
SORBITAN (UNII: 6O92ICV9RU)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white (Clear)	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	DF25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-453-09	4 in 1 CARTON	12/11/2024
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	12/11/2024

Labeler - BIONPHARMA INC. (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(69452-453)