SLEEP- diphenhydramine hcl tablet 
Salado Sales, Inc.

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CVP 44-189

Active ingredient (in each tablet)

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

  • difficulty in urination due to enlargement of the prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma

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

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

Questions or comments?

1-800-426-9391

Principal Display Panel

NIGHTTIME SLEEP AID

WAKE RESTED
AND REFRESHED

COMPARE TO
ORIGINAL FORMULA
SOMINEX® ACTIVE
INGREDIENT*

CVP®
HEALTH

SLEEP TABLETS

DIPHENHYDRAMINE HCl 25 mg
NIGHTTIME SLEEP AID

Actual Size

16 TABLETS

WAKE RESTED
AND REFRESHED

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

*This product is not manufactured or distributed by Medtech Products
Inc., owner of the registered trademark Original Formula Sominex®.
50844         REV1019S18921

Distributed by Consumer Value Products, Inc.
P.O. Box 6115, Temple, Texas 76502
CVPproducts.com

CVP 44-189

CVP 44-189

SLEEP 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57243-189
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)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorblue (light) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code 44;189
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57243-189-212 in 1 CARTON04/10/1990
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 DrugM01004/10/1990
Labeler - Salado Sales, Inc. (009830555)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(57243-189)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(57243-189) , pack(57243-189)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(57243-189)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(57243-189)

Revised: 8/2023
Document Id: bda29745-ae0f-4765-9e2e-9a47a378d3ab
Set id: 837c02dd-971b-4451-98d8-9c438c9db696
Version: 14
Effective Time: 20230814
 
Salado Sales, Inc.