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Sleep Aid NightTime by Wal-Mart Stores Inc

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Wal-Mart Stores Inc
NDC Code: 49035-654

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 44-654

Active ingredient (in each liquid-filled capsule)

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
  • trouble urinating due to an enlarged 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
  • be careful 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.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed (see overdose warning)
  • take only one dose per day (24 hours)
 adults and children 12 years and over2 capsules at bedtime if needed or as directed by a doctor
 children under 12 years 
 do not use

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • protect from light
  • see end flap for expiration date and lot number
  • avoid excessive heat above 40ºC (104ºF) and high humidity
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive ingredients

edible white ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, purified water, sorbitol

Questions or comments?

1-888-287-1915

Principal display panel

equate™

NDC 49035-654-02

Compare to VICKS® ZzzQuil™ NIGHTTIME SLEEP-AID LiquiCaps® Active ingredient*

NightTime

Sleep-Aid

Diphenhydramine HCl 25 mg
Nighttime Sleep Aid

• Non-habit
  forming

Not for Treating Cold or Flu

12
CAPSULES

Actual Size

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

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

PRODUCT OF CHINA
PACKAGED AND QUALITY ASSURED IN THE USA

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

50844  ORG061465402

Equate 44-654



SLEEP AID  NIGHTTIME
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-654
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
MINERAL OIL 
WATER 
SORBITOL 
GLYCERIN 
LECITHIN, SOYBEAN 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Product Characteristics
ColorPURPLEScoreno score
ShapeOVALSize15mm
FlavorImprint Code654
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-654-082 BLISTER PACK in 1 CARTON
112 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
2NDC:49035-654-021 BLISTER PACK in 1 CARTON
2NDC:49035-654-4212 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33802/28/2015
Labeler - Wal-Mart Stores Inc (051957769)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(49035-654)

 
Wal-Mart Stores Inc

← See all Sleep Aid NightTime brands

Medically reviewed on Aug 28, 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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