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Sleep Aid Nighttime by Wal-Mart Stores Inc

Medically reviewed on August 14, 2017

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-367

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 44-367

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg 

Purpose

Nighttime sleep-aid 

Use

for relief of occasional sleeplessness 

Warnings

Do not use
  • in 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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers. 

When using this product
  • use caution when driving a motor vehicle or operating machinery
  • drowsiness will occur
  • 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 at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use 

Other information
  • each caplet contains: calcium 30 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from moisture
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number 

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide 

Questions or comments?

1-888-287-1915

Principal Display Panel

equate™

NDC 49035-367-08

Compare to
Simply Sleep
®
Active
Ingredien
t*

Sleep-Aid
Diphenhydramine HCl 25 mg

Nighttime Sleep-Aid

• Easy to swallow

Safe, Non-Habit Forming

Does Not Contain
Pain Reliever

25
mg

24
Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING

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

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

PRODUCT OF CHINA AND JAPAN

*This product is not manufactured or distributed by McNeil Consumer Healthcare,
owner of the registered trademark Simply Sleep®.
50844         REV0516B36708

Equate 44-367

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-367
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
ANHYDROUS DIBASIC CALCIUM PHOSPHATE 
POLYVINYL ALCOHOL, UNSPECIFIED 
SILICON DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeOVALSize11mm
FlavorImprint Code44;367
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-367-082 BLISTER PACK in 1 CARTON
112 TABLET, FILM COATED in 1 BLISTER PACK
2NDC:49035-367-4212 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33806/10/2000
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(49035-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(49035-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(49035-367), PACK(49035-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(49035-367)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(49035-367)

 
Wal-Mart Stores Inc

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Further information

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

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