ALLERGY RELIEF DYE FREE- diphenhydramine hcl capsule, liquid filled
Western Family Foods, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies
- sneezing
- runny nose
- itchy, watery eyes
- itching of the nose or throat

Warnings

Do not use

with any other product containing diphenhydramine, even one used on skin
to make a child sleepy

Ask a doctor before use if you have

glaucoma
trouble urinating due to an enlarged 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

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 Center right away.

Directions

take every 4 to 6 hours
do not take more than 6 doses in 24 hours
swallow whole; do not crush, chew or dissolve

adults and children 12 years of age and over	take 1 to 2 capsules
children 6 to under 12 years of age	take 1 capsule
children under 6 years of age	do not use

Other information

store between 15-30ºC (59° to 86°F)
Protect from light, heat, humidity

Inactive ingredients

edible dye free ink, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution

Questions or comments?

Call 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

Complete Allergy

Diphenhydramine HCl 25 mg/Antihistamine

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat

*Compare to active ingredient in Benadryl® Liqui-Gels®

Dye-Free Softgels**

Softgels**

(**Liquid-filled capsules)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl®, Catalent Pharma Solutions, Inc., owner of the registered trademark LIQUI-GELS®.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Proudly Distributed bt Western Family Foods, Inc.

P.O. Box 4057, Portland, OR 97208 U.S.A.

www.westernfamily.com

Product Label

Western Family Complete Allergy Dye-Free

ALLERGY RELIEF DYE FREE
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-483
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	A33;SCU
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-483-24	24 in 1 CARTON	09/30/2015	12/31/2020
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	09/30/2015	12/31/2020

Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018

Document Id: 82b06fca-fd27-43c3-88d5-4a1570623c22

Set id: e7aba61f-090e-4844-b986-7594f53ab80a

Version: 2

Effective Time: 20181228

Western Family Foods, Inc.