SLEEP-AID NIGHTTIME- diphenhydramine hcl tablet, film coated

Sleep-Aid by

Drug Labeling and Warnings

Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by CVS PHARMACY, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

• for relief of occasional sleeplessness
• reduces time to fall asleep if you have 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
  
• difficulty in urination due to 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 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 (1-800-222-1222) right away.

Directions

• do not take more than directed
• adults and children 12 years and over: take 2 caplets (50 mg) at bedtime if needed, or as directed by a doctor
• children under 12 years: do not use

Other information

• each caplet contains: calcium 65 mg
• avoid excessive heat (greater than 100ºF) or humidity
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• use by expiration date on package

Inactive ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-800-426-9391

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Compare to the active ingredient in VICKS® ZzzQuil™*

Nighttime

Sleep-Aid
DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid

Non-habit
forming caplets

Not for treating pain, 
cold or flu

365 CAPLETS              Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 

 *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark VICKS® ZzzQuil®.

50844    REV0419A67251

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2019 CVS/pharmacy
CVS.com®
1-800-SHOP CVS

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CVS Health 44-672

INGREDIENTS AND APPEARANCE

SLEEP-AID  NIGHTTIME
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-672
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	PURPLE	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	44;672
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-672-51	365 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/24/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	07/24/2015

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(69842-672)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(69842-672) , PACK(69842-672)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(69842-672)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(69842-672)