SLEEP- diphenhydramine hcl tablet
Salado Sales, Inc.

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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CVP 44-189

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

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

do not take more than directed
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
protect from moisture
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

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

SLEEP
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57243-189
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	blue (light)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	44;189
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57243-189-21	2 in 1 CARTON	04/10/1990
1		8 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	04/10/1990

Labeler - Salado Sales, Inc. (009830555)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(57243-189)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(57243-189) , pack(57243-189)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(57243-189)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		117025878	manufacture(57243-189)

Revised: 8/2023

Document Id: 443fcfd3-dd8e-44d4-882b-f82c8b3f51d4

Set id: 837c02dd-971b-4451-98d8-9c438c9db696

Version: 13

Effective Time: 20230814

Salado Sales, Inc.