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Sleep Aid Nighttime by CVS Pharmacy

Medically reviewed on August 16, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: CVS Pharmacy
NDC Code: 59779-409

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 caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

provides relief of occasional sleeplessness

Warnings

Do not use
  • with any other products containing diphenhydramine, even one used on skin
  • in children under 12 years of age

Ask a doctor before use if you have
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • drowsiness will occur
  • avoid alcoholic drinks
  • do not drive a motor vehicle or operate machinery

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.

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

Do not take more than directed

  • adults and children 12 years of age and over: take 2 caplets at bedtime if needed or as directed by a doctor
  • children under 12 years of age: do not use

Other information
  • each caplet contains: calcium 25 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive ingredients

carnauba wax*, colloidal silicon dioxide*, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredient in TYLENOL® Simply Sleep®†

Nighttime SLEEP-AID

MINI-CAPLETS

DIPHENHYDRAMINE HCl, 25 mg

• For a restful night's sleep

• Safe, non-habit forming

Does not contain pain reliever

Mini-Caplets

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademarks TYLENOL® and Simply Sleep®.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

www.cvs.com

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Product Label

CVS Nighttime Sleep-Aid Caplet

SLEEP AID  NIGHTTIME
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-409
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
FD&C BLUE NO. 1 
ALUMINUM OXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYVINYL ALCOHOL 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUEScoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeT129;S25
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-409-242 BLISTER PACK (2 BLISTER PACK) in 1 CARTON
112 TABLET (12 TABLET) in 1 BLISTER PACK
2NDC:59779-409-011 BOTTLE, PLASTIC (1 BOTTLE) in 1 BOX
2100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33808/15/2013
Labeler - CVS Pharmacy (062312574)
Registrant - P and L Development of New York Corporation (800014821)

 
CVS Pharmacy

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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