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

Menu
Search

Nighttime 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 25 mg

Purpose

Nighttime sleep-aid

Nighttime Sleep Aid Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

Warnings

Do not use

  • with any other product containing diphenhydramine, even one used on skin
  • for children under 12 years of age
  • with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • heart disease
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers or any other sleep-aid.

When using this product

  • drowsiness will occur
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take only one dose per day (24 hours) - see Overdose warning
  • swallow whole; do not crush, chew, or dissolve
  • adults & children 12 yrs & over
    • one dose= TWO 25 mg softgels (50 mg) at bedtime if needed or as directed by a doctor

Nighttime Sleep Aid Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • protect from light

Inactive ingredients

FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol-sorbitan solution, titanium dioxide

Questions or comments?

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

Principal Display Panel

Compare to the active ingredient in ZZZQUIL®*

Nite Time Sleep- Aid

Diphenhydramine HCl 25 mg

Non Habit- Forming

NOT FOR TREATING COLD OR FLU

SEE WARNINGS

Softgels**

**Liquid-filled capsules

Product of Canada

*This product is not manufactured or distributed by The Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

Product Label

Nighttime Sleep Aid
Freds Nighttime Sleep Aid Softgels

Nighttime Sleep Aid

Diphenhydramine Hydrochloride CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-225
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
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
water
FD&C RED NO. 40
sorbitol
titanium dioxide
SORBITAN

Product Characteristics

Color Size Imprint Code Shape
PURPLE 15 mm A41 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:55315-225-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-04-11


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.