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Nighttime Sleep Aid maximum strength

Medically reviewed on January 1, 2018

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: EQUATE (Walmart Stores, Inc.)
NDC Code: 49035-230

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.

DRUG FACTS

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep- aid

Use
  • helps to reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

With other products containing diphenhydramine, even one used on skin.

Ask a doctor before use if you have
  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

Ask doctor or pharmacist before use if you are now takingsedatives or tranquilizers

When using this product

avoid alcoholic beverages

Stop use and ask a doctor if
  •  sleeplessness persists 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 right away.

Directions
  • adults and children 12 years of age and over: take 1 softgel at bedtime if needed or as directed by a doctor

Other information
  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • keep outer carton for complete warnings and product information

Inactive ingredientsedible white ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Questions?

Call: 1-888-287-1915

Principal Display Panel

Compare to Unisom SleepGels®*

Maximum Strength

Nighttime Sleep Aid

Diphenhydramine HCl

safe and non-habit forming

  • Get to sleep fast
  • sleep soundly
  • wake refreshed

Liquid Caps

One softgel per dose

Do not use if imprinted safety seal under cap is broken or missing

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Distributed by: Wal-mart stores, Inc.,

Bentonville, AR 72716

©wal-mart stores, Inc.

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

Product Label

Diphenhydramine HCl 50 mg

NIGHTTIME SLEEP AID  MAXIMUM STRENGTH
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-230
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
SORBITOL 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize13mm
FlavorImprint CodeP50;A99
Contains    
Packaging
#Item CodePackage Description
1NDC:49035-230-961 BOTTLE (1 BOTTLE) in 1 BOX
196 CAPSULE (96 CAPSULE) in 1 BOTTLE
2NDC:49035-230-031 BOTTLE (1 BOTTLE) in 1 BOX
232 CAPSULE (32 CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/06/2010
Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
Registrant - P and L Development of New York Corporation (800014821)

 
EQUATE (Walmart 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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