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

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Maximum Strength Sleep Aid

Greenbrier International, Inc.

Assured 44-293


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Maximum Strength 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 right away.

Directions

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

Maximum Strength Sleep Aid Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • protected from light
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal display panel

NDC 33992-293-19

ASSURED™

*Compare to the active ingredient in Unisom® SleepGels®

Maximum Strength
Sleep Aid
DIPHENHYDRAMINE HCl
Nighttime Sleep-Aid
Helps to reduce difficulty falling asleep

50 mg EACH

8 SOFTGELS

ITEM# 934526
Distributed by: Greenbrier International, Inc.
Chesapeake, VA 23320 USA

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Unisom® SleepGels®.
50844        REV0412A29319

Product of Canada

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

Maximum Strength Sleep Aid

Assured 44-293

Maximum Strength Sleep Aid

Diphenhydramine HCl CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-0293
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

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm A99 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 NDC:33992-0293-9 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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