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Nighttime Sleep Aid Softgels by CVS Pharmacy,Inc.

Medically reviewed on April 25, 2017

Dosage form: capsule, gelatin coated
Ingredients: Diphenhydramine Hydrochloride 25mg
Labeler: CVS Pharmacy,Inc.
NDC Code: 69842-889

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.

Nighttime Sleep-Aid Diphenhydramine HCl 24 Softgels

Drug Facts

Active ingredient (in each softgel)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses
for the 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
difficulty in urination due to enlargement of the prostate gland
heart disease

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 two 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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Directions
take only one dose per day (24 hours) - see Overdose warning

adults & children
12 yrs & over

One Dose = TWO 25 mg Softgels (50 mg)
at bedtime if needed or as directed by a doctor

Other information
store at 20-25° C (68-77° F)
avoid excessive heat above 40°C (104° F) and high humidity
protect from light

Inactive ingredients

FD&C blue 1, FD&C red 40, gelatin, glycerin, methyl paraben, polyethylene glycol, propyl paraben, purified water, sorbitol, titanium dioxide

PRINCIPAL DISPLAY PANEL

CVS Health

Compare to the active ingredient in ZzzQuil LiquiCaps®*


Nighttime

 
Sleep-Aid


DIPHENHYDRAMINE HCL

Non- habit forming softgels

Not for treating cold or flu

24 SOFTGELS

SEE NEW WARNINGS

Failure to follow these warnings could result in serious consequences.

TAMPER EVIDENT: THIS PACKAGE IS SAFETY SEALED & CHILD RESISTANT. USE ONLY IF BLISTERS ARE INTACT. IF DIFFICULT TO OPEN, USE SCISSORS.

Distributed by:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2015 CVS/pharmacy

CVS.com® 1-800-SHOP CVS

V-30486

CVS® Quality

Money Back Guarantee

*This product is not manufactured or distributed by Proctor & Gamble, the distributor of ZzzQuil® LiquiCaps®.

NIGHTTIME SLEEP AID SOFTGELS 
diphenhydramine hydrochloride capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-889
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 
glycerin 
METHYLPARABEN 
polyethylene glycols 
PROPYLPARABEN 
water 
sorbitol 
titanium dioxide 
Product Characteristics
ColorPURPLEScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code060;R060
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-889-242 BLISTER PACK in 1 CARTON
112 CAPSULE, GELATIN COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33811/17/2015
Labeler - CVS Pharmacy,Inc. (062312574)

 
CVS Pharmacy,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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