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Salado Sales, Inc.

CVP 44-189


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Sleep Uses

helps 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

  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland 

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers 

When using this product

  • avoid alcoholic drinks 

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

  •  adults and children 12 years and older, take 2 tablets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Sleep Other information

  • store at controlled room temperature 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

 1-800-426-9391

Principal Display Panel

CVP®
CONSUMER VALUE PRODUCTS

COMPARE TO SOMINEX® ACTIVE INGREDIENT*

SLEEP TABLETS
NIGHTTIME SLEEP AID • DIPHENHYDRAMINE HCl 25 mg
Wake Rested AND Refreshed

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

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, owner of the registered trademark Sominex®. 50844   REV0410M18921

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

Sleep

Sleep

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:57243-189
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
CROSCARMELLOSE SODIUM
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C BLUE NO. 1
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
BLUE 10 mm 44;189 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 16 in 1 BLISTER PACK
2 NDC:57243-189-21 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 1990-04-10


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Be sure to consult your doctor before taking any medication!
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