Diphenhydramine HCl description, usages, side effects, indications, overdosage, supplying and lots more!

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Diphenhydramine HCl

Softech Pharma Pvt. Ltd

Diphenhydramine HCl 25 mg


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient in each Softgel

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Keep out of reach of Children

Diphenhydramine HCl Uses

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

Warnings

Do not use

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

Directions

Take only one dose per day (24 hours) - see Overdose warning

adults & children 12 yrs & over One dose = Two 25 mg Softgels (50 mg) at bedtime if needed or as directed by a doctor

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, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Principal Display Panel

Diphenhydramine Hydrochloride Capsules, USP 25 mg

Diphenhydramine HCl

Diphenhydramine HCl

Diphenhydramine HCl CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48769-060
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
FD&C RED NO. 40
GELATIN
GLYCERIN
METHYLPARABEN
polyethylene glycol 400
PROPYLPARABEN
water
sorbitol
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
purple 7 mm R60 capsule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:48769-060-99 5000 in 1 BAG

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2013-01-01


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Be sure to consult your doctor before taking any medication!
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