Docusate Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

Docusate Sodium

NCS HealthCare of KY, Inc dba Vangard Labs

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Docusate Sodium 100mg

Stool softener

  • for the prevention of dry, hard stools
  • for relief of occasional constipation.

This product generally produces a bowel movement within 12 to 72 hours.

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea or vomiting are present
  • for longer than 1 week, unless directed by a doctor

you notice a sudden change in bowel habits that persists over a period of 2 weeks

  • you have rectal bleeding
  • you fail to have a bowel movement after use

ask a health care professional before use.

In case of overdose, get medical help or contact a Poison Control Center right away.

  • adults and children over 12 years of age: take 1 to 3 softgels preferably at bedtime
  • children 6- 12 years of age: take 1 softgel at bedtime
  • each softgel contains: sodium 6mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • *This product is not manufactured or distributed by Purdue Pharma L.P., owner of the registered trademark Colace®

edible ink, FDandC Red #40, FDandC Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Adverse Drug Event Call: (800)-616-2471)

Distributed by : Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

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Docusate Sodium

DOCUSATE SODIUM CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0615-0585(NDC:0904-7889)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM DOCUSATE 100 mg

Inactive Ingredients

Ingredient Name Strength
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
propylene glycol
water
sorbitol

Product Characteristics

Color Size Imprint Code Shape
ORANGE (ORANGE) 13 mm P51 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0615-0585-05 15 in 1 BLISTER PACK
2 NDC:0615-0585-31 31 in 1 BLISTER PACK
3 NDC:0615-0585-39 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-04-23


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