NIGHTTIME SLEEP AID description, usages, side effects, indications, overdosage, supplying and lots more!

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NIGHTTIME SLEEP AID

PuraVation Pharmaceuticals Inc

NIGHTTIME SLEEP AID capsule, liquid filled


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

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 give to children under 12 years of age
  • do not use 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 persist 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. 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 room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • do not use if imprinted safety seal under cap is broken or missing

Inactive ingredients

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special and white edible ink

PRINCIPAL DISPLAY PANEL

NIGHTTIME SLEEP AID

Liquidcaps

Maximum Strength

Diphenhydramine HCl 50 mg

32 Liquidcaps

Compare to the active ingredient in Maximum Strength Unisom Sleep Gels® 

NIGHTTIME SLEEP AID

NIGHTTIME SLEEP AID

DIPHENHYDRAMINE HYDROCHLORIDE 50 mg CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76270-109
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

Product Characteristics

Color Size Imprint Code Shape
blue 13 mm PC5 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BOTTLE, PLASTIC
2 64 in 1 BOTTLE, PLASTIC
3 NDC:76270-109-17 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-04-15


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Be sure to consult your doctor before taking any medication!
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