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

Menu
Search

Nighttime Sleep Aid

Greenbrier International, Inc.

Assured 44-367


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Nighttime Sleep Aid Uses

relief of occasional sleeplessness

Warnings

Do not use

  • in children under 12 years of age

  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if

  • 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

taking sedatives or tranquilizers.

When using this product

  • drowsiness will occur

  • avoid alcoholic drinks

  • do not drive a motor vehicle or operate machinery

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

Overdose warning: In case of overdose, get medical help or In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed
    (see Overdose warning)

  • adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor

  • children under 12 years: do not use

Nighttime Sleep Aid Other information

  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silica gel, stearic acid, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

ASSURED™

COMPARE TO ACTIVE INGREDIENT IN SIMPLY SLEEP®

Safe, Non-habit Forming

Nighttime
Sleep Aid
DIphenhydramine HCl 25 mg
Nighttime sleep-aid

Does NOT Contain Pain Reliever
Wake Up Rested and Refreshed

36 Caplets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Simply Sleep®,
50844    REV0612A36707

TAMPER EVIDENT: DO NOT USSE IF CARTON IS OPENED OR IF BLISTER SHOWS ANY SIGNS OF TAMPERING 

Nighttime Sleep Aid
Assured 44-367

Nighttime Sleep Aid

Diphenhydramine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-0367
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C BLUE NO. 1
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POLYVINYL ALCOHOL
STEARIC ACID
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm 44;367 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 36 in 1 BLISTER PACK
2 NDC:33992-0367-7 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2000-06-10


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.