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 Whole Foods Market, 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

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP JS BROKEN OR MISSING

KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WHOLE FOODS MARKET | 550 BOWIE STREET, AUSTIN, TX 78703 | © 2020 WHOLE FOODS MARKET IP, INC | www.wholefoodsmarket.com

PRODUCT OF INDIA | ** THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY THE OWNERS OF BENADRYL ® ALLERGY LIQUI-GELS ®

Mfg.Lic. No. : TN00002123

2122772

L0000952

R0125

30's count

NDC: 42681-0050-1

365

WHOLE FOODS MARKET

Antihistamine

Allergy Relief

Diphenhydramine HCl

Capsules USP, 25 mg

Sneezing | Runny nose

Itchy, Watery Eyes | Itchy Throat or Nose

** Compare to the Active Ingridient in

Benadryl ® Allergy LIQUI-GELS ®

30

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: 42681-0050
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: 42681-0050-1	1 in 1 CARTON	02/27/2025
1		30 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	02/27/2025

Labeler - Whole Foods Market, INC. (196175616)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
SOFTGEL HEALTHCARE PRIVATE LIMITED		675584180	manufacture(42681-0050)