SLEEP AID- diphenhydramine hcl tablet

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

to help 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 caplets (50 mg) at bedtime if needed or as directed by a doctor

Other information

• each caplet contains: calcium 85 mg
• store at controlled room temperature 15°-30°C (59°-86°F)
• do not use if imprinted safety seal under cap is broken or missing
• *This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Nytol®

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose and silicon dioxide.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

*Compare to the active ingredient in Nytol®

SLEEP AID

Diphenhydramine Hydrochloride 25 mg

Nighttime Sleep Aid

Distributed by:

CHAIN DRUG CONSORTIUM, LLC.

BOCA RATON, FL 33431

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Diphenhydramine HCl 25 mg

INGREDIENTS AND APPEARANCE

SLEEP AID 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-189
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)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	15mm
Flavor		Imprint Code	93XF;57344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-189-60	1 in 1 BOX
1		60 in 1 BOTTLE; 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

Labeler - Chain Drug Consortium, LLC (101668460)