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Sleep- Aid Nighttime by CVS Pharmacy

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CVS Pharmacy
NDC Code: 69842-682

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 44-682

Active ingredient (in each mini-capsule)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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
  • difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

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

adults and children 12 years and over: take 2 mini-capsules (50 mg) at bedtime if needed, or as directed by a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number
  • protect from moisture

Inactive ingredients

butylparaben, corn starch, FD&C blue #1, FD&C red #3, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, 
povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium hydroxide, titanium dioxide

Questions or comments?

1-800-426-9391

Principal display panel

CVS Health

Compare to the active ingredient in Unisom® SleepMinis™*

Mini-Capsules

NDC 69842-682-11

Nighttime
Sleep-Aid
DIPHENHYDRAMINE HCl, 25 mg
Nighttime sleep-aid

Non-habit forming

60 MINI-CAPSULES

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS
BROKEN ON MISSING OR IF BLUE BAND AROUND CAPSULE IS BROKEN OR MISSING 

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

50844    ORG021668211

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2016 CVS/Pharmacy
CVS.com® 1-800-SHOP CVS  V-11112

CVS®Quality
Money Back Guarantee

CVS 44-682

SLEEP- AID  NIGHTTIME
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-682
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLPARABEN 
STARCH, CORN 
FD&C BLUE NO. 1 
FD&C RED NO. 3 
GELATIN 
LACTOSE, UNSPECIFIED FORM 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
POVIDONE 
PROPYLPARABEN 
SHELLAC 
SILICON DIOXIDE 
SODIUM HYDROXIDE 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (light blue) , BLUE (dark blue) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code44;682
Contains    
Packaging
#Item CodePackage Description
1NDC:69842-682-111 BOTTLE in 1 CARTON
160 CAPSULE in 1 BOTTLE
2NDC:69842-682-51365 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33807/31/2016
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(69842-682)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088MANUFACTURE(69842-682), PACK(69842-682)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(69842-682)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(69842-682)

 
CVS Pharmacy

← See all Sleep- Aid Nighttime brands

Medically reviewed on Nov 12, 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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