NIGHTTIME SLEEP AID- diphenhydramine hcl tablet, film coated 
CVS Pharmacy

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CVS 44-367

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

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 right away.

Directions

Other information

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

♥CVS Health®

Compare to the active
ingredient in Simply Sleep®*

Mini-Caplets

Nighttime
Sleep-Aid

DIPHENHYDRAMINE HCl, 25 mg
Nighttime Sleep-Aid

Helps to reduce difficulty
in falling asleep

Does not contain
pain reliever

Actual Size

Package Contains
  One Bottle 

225 MINI-CAPLETS

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

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Simply Sleep®.

50844             REV1019A36720

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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V-11112

CVS 44-367

CVS 44-367

NIGHTTIME SLEEP AID 
diphenhydramine hcl tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-367
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize11mm
FlavorImprint Code 44;367
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-367-082 in 1 CARTON06/10/2000
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:59779-367-224 in 1 CARTON06/10/2000
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:59779-367-121 in 1 CARTON06/10/2000
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:59779-367-51365 in 1 BOTTLE; Type 0: Not a Combination Product06/10/2000
5NDC:59779-367-201 in 1 CARTON06/10/2000
5225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01006/10/2000
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(59779-367)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(59779-367) , pack(59779-367)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894manufacture(59779-367)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088manufacture(59779-367)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(59779-367)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(59779-367)

Revised: 1/2023
Document Id: 4b45bee0-9caa-4110-b37d-0dace2cc097f
Set id: 3710254e-6c3c-4044-9694-59703274cd0f
Version: 20
Effective Time: 20230125
 
CVS Pharmacy