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nighttime sleep aid by CVS Pharmacy

Medically reviewed on January 24, 2018

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 50mg
Labeler: CVS Pharmacy
NDC Code: 69842-439

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 Pharmacy, Inc. Nighttime Sleep-Aid Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use
for relief of occasional sleeplessness

Warnings

Do not use
for 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
glaucoma
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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 (1-800-222-1222).

Directions
adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Other information
store at 20-25°C (68-77°F)

Inactive ingredients

edible dye-free ink*, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

1-800-719-9260

Principal Display Panel

VALUE SIZE 60 SOFTGELS

Compare to the active ingredient in Unisom® SleepGels®

SoftGels

Nighttime Sleep-Aid

DIPHENHYDRAMINE HCl 50 mg

Free of artificial dyes & preservatives

Non-habit forming

One softgel per dose

60 SOFTGELS

Actual Bottle Size on Top Panel

Actual Size

NIGHTTIME SLEEP AID 
diphenhydramine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-439
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE50 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
WATER 
Product Characteristics
ColorYELLOW (Translucent Clear) Scoreno score
ShapeOVALSize13mm
FlavorImprint Code6N6
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-439-331 BOTTLE in 1 CARTON
160 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33801/15/2018
Labeler - CVS Pharmacy (062312574)

 
CVS Pharmacy

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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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