SLEEP-AID REGULAR STRENGTH- diphenhydramine hcl tablet 
CVS Pharmacy

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.

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CVS 44-189-Discontinued

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty falling asleep

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
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers. 

When using this product

  • use caution when driving a motor vehicle or operating machinery
  • avoid alcoholic beverages
  • drowsiness will occur

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 tablets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information

  • each tablet contains: calcium 60 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number
  • protect from moisture
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) 

Inactive ingredients

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Principal Display Panel

CVSHealth

Compare to the active ingredient
in Original Formula Sominex®*

NDC 59779-999-23


SLEEP-AID
DIPHENHYDRAMINE HCl, 25 mg

Nighttime sleep-aid

Wake rested & refreshed

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

Actual Size

72 Tablets

*This product is not manufactured or distributed by Prestige Brands, Inc., owner of the registered trademark Original Formula Sominex®.
50844        REV0516A18923

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2017 CVS/pharmacy
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CVS® Quality
Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN, OR SHOWS ANY SIGNS OF TAMPERING

CVS 44-189

CVS 44-189


SLEEP-AID  REGULAR STRENGTH
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-999
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;189
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-999-239 in 1 CARTON04/10/199012/19/2021
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33804/10/199012/19/2021
Labeler - CVS Pharmacy (062312574)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(59779-999)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(59779-999)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(59779-999)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(59779-999)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(59779-999)

Revised: 3/2019
 
CVS Pharmacy