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Sleep-Aid Nighttime by CVS Pharmacy

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CVS Pharmacy
NDC Code: 69842-672

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

CVS 44-672

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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have
  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • heart disease
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep aid.

When using this product
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • use caution when driving a motor vehicle or operating 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 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 70 mg
  • avoid excessive heat (greater than 100ºF) and 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, 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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CVS
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Compare to the active ingredient in VICKS® ZzzQuil™*

NDC 69842-672-51

Nighttime

Sleep-Aid
DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid

Non-habit
forming caplets

Not for treating 
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 Procter & Gamble, owner of the trademarks VICKS® ZzzQuil™.

50844    ORG021567251

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895
© 2017 CVS/pharmacy
CVS.com®
1-800-SHOP CVS

V-11112

CVS®Quality
Money Back Guarantee 

CVS 44-672

SLEEP-AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-672
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
D&C RED NO. 27 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
POLYVINYL ALCOHOL, UNSPECIFIED 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize14mm
FlavorImprint Code44;672
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-672-51365 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/24/2015
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(69842-672)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(69842-672), PACK(69842-672)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(69842-672)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(69842-672)

 
CVS Pharmacy

← See all Sleep-Aid Nighttime brands

Medically reviewed on Nov 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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