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

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Leader Maximum Strength Sleep Aid

Cardinal Health

Leader Nighttime Sleep Aid Maximum Strength


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each softgel)

Diphenhydramine HCl 50mg

Purpose

Nighttime sleep aid

Use

helps to 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 or pharmacist before use if you have

emphysema

chronic bronchitis

glaucoma

difficulty in urination due to an enlargement of the prostate gland

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 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 of age and over: take 1 softgel at bedtime if needed or as
directed by a doctor

Leader Maximum Strength Sleep Aid Other information

  • 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 Chattem, Inc., owner of the registered trademark Maximum Strength Unisom® SleepGels®.




edible white ink, FDandC Blue #1, gelatin, glycerin, polyethylene glycol, purified water and sorbitol special.

Questions or comments?

Call toll free: 1-800-200-6313

Distributed by:
Cardinal Health
Dublin, Ohio 43017

All Leader Brand Products are 100% satisfation guaranteed or return to place of purchase for a full refund

*Compare to Maximum Strength Unisom® SleepGels®

NDC 37205-0120-64

Maximum Strength Sleep Aid

Diphenhydramine HCl

Helps to reduce difficulty falling asleep

32 softgels

Container Label

Leader Maximum Strength Sleep Aid

Outer Carton Label

Leader Maximum Strength Sleep Aid

Leader Maximum Strength Sleep Aid

DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:37205-120
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
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
blue (BLUE) 13 mm P50;A99 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BOTTLE
2 NDC:37205-120-64 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2012-06-05


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