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 50 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

■ 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)

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF 
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-452
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
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
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 Transparent)	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	DF50
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-452-20	1 in 1 CARTON	10/01/2024
1		100 in 1 BOTTLE; 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	10/01/2024

Labeler - BIONPHARMA INC. (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(69452-452)