NIGHTTIME SLEEP AID- diphenhydramine hcl tablet

Nighttime Sleep Aid by

Drug Labeling and Warnings

Nighttime Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

with other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• emphysema

• chronic bronchitis

• glaucoma

• difficulty in urination due to an 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.

stop use and ask a doctor if

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

If pregnant of breast-feeding,

ask a health care 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. For best results, take recommended dose. This will provide approximately 6 to 8 hours of restful sleep.

Other information

• each tablet contains: calcium 65 mg
• store at controlled room temperature 15°-30°C (59°-86°F)
• avoid excessive heat and humidity
• *This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Sominex®

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Blue #1 aluminium lake, magnesium stearate and microcrystalline cellulose

May also contain: silicon dioxide and stearic acid

Principal Display Panel

Compare to the active ingredient in Sominex®*

SLEEP TABLETS

Diphenhydramine Hydrochloride 25 mg

Nighttime Sleep Aid

Proudly Distributed by Western Family Foods, Inc.,

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Questions or comments? Call toll free 1-877-753-3935

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Diphenhydramine HCl 25 mg

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55312-200
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	1008;1008
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55312-200-16	2 in 1 CARTON	07/12/2010	12/31/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part336	07/12/2010	12/31/2020

Labeler - Western Family Foods, Inc. (192166072)