Nighttime Sleep Aid description, usages, side effects, indications, overdosage, supplying and lots more!

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Nighttime Sleep Aid

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-293


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Nighttime Sleep Aid Uses

for relief of occasional sleeplessness

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

  • 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 (1-800-222-1222) right away.

Directions

  • adults and children 12 years and over:
    1 softgel at bedtime if needed, or as directed by a doctor

Nighttime Sleep Aid Other information

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

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, sorbitol

Questions or comments?

1-800-426-9391

Principal display panel

CVS®
pharmacy

Compare to the active ingredient in Unisom® SleepGels®*

NIGHTTIME
SLEEP AID
MAXIMUM STRENGTH
DIPHENHYDRAMINE HCl 50 mg

Non-habit forming

8 Softgels

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®.
50844    REV0211A29319

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
(c) 2011 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

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

Nighttime Sleep Aid
CVS 44-293

Nighttime Sleep Aid

Diphenhydramine HCl CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-970
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
GELATIN
sorbitol
FD&C BLUE NO. 1
GLYCERIN

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm A33 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:59779-970-19 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part336 2004-04-08


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Be sure to consult your doctor before taking any medication!
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