SLEEP NIGHTTIME SLEEP AID- diphenhydramine hcl tablet
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 tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

Helps to reduce difficulty falling asleep.

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: take 2 tablets at bedtime if needed or as directed by a doctor

Other information

each tablet contains: calcium 65 mg
store at 15º-30ºC (59º-86ºF)

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose

Questions or comments?

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

Principal Display Panel

SEALED IN BLISTER UNIT FOR YOUR PROTECTION

Wake Rested and Refreshed

Diphenhydramine HCl 25 mg

SleepTABLETS

Nighttime Sleep-Aid

TABLETS

COMPARE TO THE ACTIVE INGREDIENT IN SOMINEX®*

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Sominex®.

Proudly Distributed by Western Family Foods, Inc.

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

www.westernfamily.com

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Package Label

Western Family Sleep Tablets

SLEEP NIGHTTIME SLEEP AID
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-252
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	1008;1008
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-252-16	16 in 1 CARTON	02/28/2014	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	part338	02/28/2014	12/31/2020

Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018

Document Id: d5a1392a-333f-4488-91a2-86c964d931e3

Set id: 408c646f-9c36-4ebf-8459-af287473b4e1

Version: 3

Effective Time: 20181227

Western Family Foods, Inc.