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Sleep Aid

Chain Drug Consortium, LLC (Premier Value)

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

to help reduce difficulty falling asleep

Warnings

Do not give to children under 12 years of age.

Do not use this product

with other products containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • emphysema

  • chronic bronchitis

  • glaucoma

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

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 for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant of breast-feeding,

ask a health care 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 of age and over: take 2 caplets (50 mg) at bedtime if needed or as directed by a doctor

Sleep Aid Other information

  • each caplet contains: calcium 85 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Glaxosmithkline, owner of the registered trademark Nytol®

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose and silicon dioxide.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

*Compare to the active ingredient in Nytol®

SLEEP AID

Diphenhydramine Hydrochloride 25 mg

Nighttime Sleep Aid

Distributed by:

CHAIN DRUG CONSORTIUM, LLC.

BOCA RATON, FL 33431

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Sleep Aid
Diphenhydramine HCl 25 mg

Sleep Aid

Diphenhydramine HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-189
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
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
WHITE 15 mm 93XF;57344 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:68016-189-60 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2010-07-12


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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