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

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Sleep-Aid

Freds Inc
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

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 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 now 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 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

Sleep-Aid Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

Questions or comments?

Call toll free 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Sleep-Aid

Maximum Strength

Nighttime Sleep-Aid

Diphenhydramine HCl, 50 mg

Softgels

Compare to the active ingredient in Maximum Strength Unisom® SleepGels®*

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN  38118

www.fredsinc.com

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

Product Label

Sleep-Aid
Fred's Sleep-Aid Maximum Strength

Sleep-Aid

Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-230
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
SORBITAN

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm P50;A99 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BOTTLE, PLASTIC
2 NDC:55315-230-32 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-03-15


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Be sure to consult your doctor before taking any medication!
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