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 Chain Drug Consortium, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

• helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

• With any other product 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 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 or 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 and over: take 2 tablets at bedtime 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.

Product Label

*Compare to the active ingredient in Sominex®

Nighttime sleep aid

Diphenhydramine HCl 25mg

wake rested and refreshed

DISTRIBUTED BY:

CHAIN DRUG CONSORTIUM, LLC.

BOCA RATON, FL 33431

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

Nighttime sleeo aid Diphenhydramine HCl 25 mg

INGREDIENTS AND APPEARANCE

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-187
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)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-187-16	2 in 1 CARTON	07/08/2010	12/31/2020
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 68016-187-32	4 in 1 CARTON	07/08/2010	12/31/2020
2		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	part341	07/08/2010	12/31/2020

Labeler - Chain Drug Consortium, LLC (101668460)