Your browser does not support JavaScript! SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [CVS PHARMACY]
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RxNorm Names

SLEEP AID (diphenhydramine hydrochloride) tablet
[CVS Pharmacy]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Warnings

Do not use

  • in 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
  • 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

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 and over		take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 yearsdo not use

Other information

  • each caplet contains: calcium 15 mg
  • store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredient in 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

Sleep-Aid Carton Image 1

Sleep-Aid Carton Image 1

Sleep-Aid Carton Image 2

Sleep-Aid Carton Image 2

SLEEP AID 
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-431
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
CROSPOVIDONE 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
POLYSORBATE 80 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
ColorBLUE (Light Blue) Scoreno score
ShapeCAPSULESize11mm
FlavorImprint Code L431
Contains    
Packaging
#Item CodePackage Description
1NDC:59779-431-622 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:59779-431-781 in 1 CARTON
2100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33810/03/2000
Labeler - CVS Pharmacy (062312574)

Revised: 03/2012
Document Id: 584ca686-2085-448c-a370-fda370d379d2
Set id: 584ca686-2085-448c-a370-fda370d379d2
Version: 1
Effective Time: 20120312
 
CVS Pharmacy

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