SLEEP AID NIGHTTIME- diphenhydramine hydrochloride tablet

Sleep Aid by

Drug Labeling and Warnings

Sleep Aid by is a Otc medication manufactured, distributed, or labeled by H E B. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Diections

• take only one dose (2 tablets) per day (24 hours)
• 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 between 15-30ºC (59-86ºF)

Inactive Ingredients

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

Questions or Comments

Call toll free 1-877-753-3935 Monday-Friday 9AM – 5PM EST

 

Principal Display Panel

Compare to Sominex® active ingredient**

Nighttime Sleep-Aid

Diphenhydramine HCl 25 mg

Help You Fall Asleep

Safe and Effective

TABLETS

**This product is not manufactured or distributed by Prestige Brands Inc., distributor of Sominex®.

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.

MADE WITH PRIDE AND CARE FOR H-E-B®,

SAN ANTONIO, TX 78204

Package Label

H-E-B Nighttime Sleep-Aid

INGREDIENTS AND APPEARANCE

SLEEP AID  NIGHTTIME
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-252
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, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ALUMINUM OXIDE (UNII: LMI26O6933)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-252-32	32 in 1 BOX	08/31/2014
1		1 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	part338	08/31/2014

Labeler - H E B (007924756)