DYE-FREE ALLERGY RELIEF- diphenhydramine hcl capsule, liquid filled
CHAIN DRUG MARKETING ASSOCIATION 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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Quality Choice 44-299-Delisted

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

to make a child sleepy
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
trouble urinating due to an enlarged prostate gland

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

adults and children 12 years of age and over	1 to 2 softgels
children 6 to under 12 years of age	1 softgel
children under 6 years of age	do not use this product in children under 6 years of age

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from heat, humidity and light
see end flap for expiration date and lot number

Inactive ingredients

gelatin, glycerin, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

NDC 63868-995-24

QC
QUALITY
CHOICE®

*Compare to the active ingredient in BENADRYL® Dye-Free Allergy LIQUI-GELS®

Dye-Free
Allergy Relief
Complete Allergy Relief
Diphenhydramine HCl 25 mg | Antihistamine

Allergy Relief for:
Sneezing, Runny Nose
Itchy, Watery Eyes, Itchy Throat

24 Clear Softgels (25 mg Each)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark BENADRYL® Dye-Free Allergy LIQUI-GELS®.
50844 REV0412A29908

Product of Canada

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

QualityChoice44-299

DYE-FREE ALLERGY RELIEF
diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-995
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)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	YELLOW (clear)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	A33
Contains

#	Item Code	Package Description
Packaging
1	NDC:63868-995-24	3 in 1 CARTON
1		8 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	09/13/2001	07/13/2018

Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
Accucaps Industries, Ltd.		248441727	MANUFACTURE(63868-995)

Revised: 7/2015

Document Id: c6c9cb0a-75a4-4a18-874e-5d87cf6bfc58

Set id: b425d30d-a7c1-478a-87c6-86a30e825816

Version: 3

Effective Time: 20150713

CHAIN DRUG MARKETING ASSOCIATION INC