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Sleep Aid NightTime by Wal-Mart Stores Inc

Medically reviewed on March 29, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-672

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.

Equate 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
  • with any other product containing diphenhydramine, even one used on skin
  • for children under 12 years of age
  • 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) 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, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-888-287-1915

Principal display panel

equate™

NDC 49035-672-51

Compare to
VICKS®
ZzzQuil™
Active
Ingredient*

NightTime
Sleep-Aid

 Diphenhydramine HCl 25 mg
Nighttime Sleep Aid
• Non-habit Forming

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

Satisfaction guaranteed - For questions or comments
please call 1-888-287-1915.

DISTRIBUTED BY: Wal-Mart Stores, Inc.,
Bentonville, AR 72716

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

50844    ORG021567251

Equate 44-672

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-672
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 
FD&C BLUE NO. 2 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
TALC 
TITANIUM DIOXIDE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize14mm
FlavorImprint Code44;672
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-672-51365 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/24/2015
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49035-672)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(49035-672)

 
Wal-Mart Stores Inc

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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