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

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Sleep Aid

P and L Development of New York Corporation (ReadyInCase)

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each softgel)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

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 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: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

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 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

• Fall Asleep Fast  • Sleep Soundly  • Wake up Refreshed

SOFTGELS Liquid Filled

One Softgel Per Dose

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

Distributed by:

PL Developments

200 Hicks Street

Westbury, NY 11590

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Package Label

Sleep Aid
ReadyInCase Maximum Strength Nighttime Sleep-Aid Softgel

Sleep Aid

Diphenhydramine HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59726-236
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 8 in 1 BLISTER PACK
2 32 in 1 BOTTLE, PLASTIC
3 NDC:59726-236-32 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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