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

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Nighttime Sleep Aid

Premier Value (Chain Drug Consortium, LLC)
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

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

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • 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 of 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: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Nighttime Sleep Aid Other information

  • store at 15°-30°C (59°-86°F)

Inactive ingredients

edible white ink, FD&C blue #1, gelatin, glycerin, light mineral oil*, polyethylene glycol, purified water, sorbitol-sorbitan

*may contain this ingredient

Questions or comments?

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

Principal Display Panel

**COMPARE TO THE ACTIVE INGREDIENT IN UNISOM® SLEEPGELS®

MAXIMUM STRENGTH

Nighttime Sleep-Aid

DIPHENHYDRAMINE HCl, 50 mg

Safe, Non-Habit Forming

Liquid Filled Softgels

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: 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 Unisom® SleepGels®.

DISTRIBUTED BY: CHAIN DRUG CONSORTIUM, LLC.

3301 NW BOCA RATON BLVD., SUITE 101 BOCA RATON, FL 33431

Product Label

Nighttime Sleep Aid
Premier Value Maximum Strength Nighttime Sleep Aid Softgel

Nighttime Sleep Aid

Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-376
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
LIGHT MINERAL OIL
POLYETHYLENE GLYCOLS
water
SORBITAN
sorbitol

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm P50;A99;S90 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BOTTLE, PLASTIC
2 NDC:68016-376-32 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-02-01


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