SLEEP- diphenhydramine hcl tablet

Sleep by

Drug Labeling and Warnings

Sleep by is a Otc medication manufactured, distributed, or labeled by Salado Sales, Inc., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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
• use caution when driving a motor vehicle or operating machinery
• 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
• 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

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 Prestige Brands,
Inc., owner of the registered trademark Original Formula Sominex®.
50844         REV0516R18921

Distributed by Salado Sales, Inc., P.O. Box 6115, Temple, Texas 76503
www.CVPproducts.com

CVP 44-189

INGREDIENTS AND APPEARANCE

SLEEP 
diphenhydramine hcl tablet

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

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	04/10/1990

Labeler - Salado Sales, Inc. (009830555)

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

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(57243-189)

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

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

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(57243-189)