NIGHTTIME SLEEP AID MAXIMUM STRENGTH- diphenhydramine hcl capsule
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 softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Purpose

Nighttime sleep-aid

Use

for relief of occasional sleeplessness.

Warnings

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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
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

avoid alcoholic drinks.

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

Safe & Effective Fall Asleep FAST!

Maximum Strength

**Compare to the Active Ingredient in Unisom® SleepGels®

Nighttime Sleep Aid

Diphenhydramine HCl 50 mg

LIQUID FILLED Softgels

1 Softgel Dosage

**This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®.

Proudly Distributed by Western Family Foods, Inc.

P.O. Box 4057, Portland, OR 97208 USA

www.westernfamily.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label

Western Family Maximum Strength Nighttime Sleep-Aid

NIGHTTIME SLEEP AID MAXIMUM STRENGTH
diphenhydramine hcl capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-236
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	P50;A99;S90
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-236-32	1 in 1 BOX	02/01/2014	12/31/2020
1		32 in 1 BOTTLE, PLASTIC; 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	02/01/2014	12/31/2020

Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018

Document Id: 73697637-50b0-4bd3-9d1b-eacb06a44987

Set id: b3214eec-9fc3-4487-abe1-04947c2548a7

Version: 7

Effective Time: 20181227

Western Family Foods, Inc.