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

Docusate Sodium

McKesson Packaging Services Business Unit of McKesson Corporation

  • 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

Active ingredient

Docusate Sodium 100mg

Purpose

Stool Softener

Uses

  • •for the prevention of dry, hard stools
  • •for relief of occasional constipation.
  • •This product generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not use

  • •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

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

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

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 over 12 years of age: take 1-2 capsules, preferably at bedtime
  • Children 6-12 years of age: take 1 capsule at bedtime

Other information

  • each capsule contains: sodium 5 mg
  • •store at controlled room temperature 15° - 30°C (59° - 86°F)

Inactive ingredients

FD&C red #40, gelatin, glycerin, polyethylene glycol, propyleneglycol and sorbitol special. May also contain: D&C yellow #10, FC&C yellow #6 and purified water.

Principal Display Panel

Principal Display Panel

Docusate Sodium

Docusate Sodium CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63739-478
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
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
propylene glycol
sorbitol
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
water

Product Characteristics

Color Size Imprint Code Shape
RED (Reddish) 12 mm SCU1 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 30 in 1 BLISTER PACK
2 10 in 1 BLISTER PACK
3 NDC:63739-478-10 10 in 1 BOX, UNIT-DOSE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-11-09


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