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 EQUALINE (SuperValu). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

provides relief of occasional sleeplessness

Warnings

Do not use

• with any other products containing diphenhydramine, even one used on skin
• in children under 12 years of age.

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis

• trouble urinating due to an enlarged prostate gland

• glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

• drowsiness will occur
• avoid alcoholic beverages
• do not drive a motor vehicle or operate machinery

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 of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: In the case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not take more than directed

• adults and children 12 years of age and over: take 2 caplets at bedtime if needed or as directed by a doctor
• children under 12 years of age: do not use

Other information

• each caplet contains: calcium 25 mg
• store at controlled room temperature 15°-30°C (59°-86°F)
• avoid excessive heat and humidity

Inactive ingredients

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake,
magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-932-7948

Principal Display Panel

Compare to TYLENOL® SIMPLY SLEEP® active ingredient**

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Simply Sleep®

NIGHTTIME SLEEP-AID

Diphenhydramine HCl, 25 mg

• helps to fall asleep fast
• for a restful night's sleep
• safe, non-habit forming

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Tamper evident: Do not use if imprinted safety seal under cap is broken or missing

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: 41163-401
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ALUMINUM OXIDE (UNII: LMI26O6933)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	T129;S25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-401-24	2 in 1 CARTON	10/31/2012	10/31/2020
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41163-401-01	1 in 1 BOX	10/31/2012	10/31/2020
2		100 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	10/31/2012	10/31/2020

Labeler - EQUALINE (SuperValu) (006961411)