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

Docusate Sodium

American Health Packaging

  • 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, USP 100mg

Purpose

Stool Softener

Uses

  • For relief of occasional constipation.
  • This product generally produces a bowel movement within 12 to 72 hours.
  • Helps to prevent dry, hard stools.

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 one 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 or 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 orally 1 to 2 softgels at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
  • Children 6-12 years of age: Take orally softgels at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.
  • Children under 6 years of age: Do not us this product for children under 6 years of age, unless directed by a doctor.

Other information

  • Each capsule contains 5 mg of Sodium.
  • Store at room temperature 15° - 30°C (59° - 86°F).

Inactive ingredients

FD&C Red #40, Gelatin, Glycerin, Polyethylene Glycol 400, Sorbitol Special, FD&C Yellow #6 and Purified Water.

Manufactured & Distributed by:

Swiss Caps USA, Inc.

Miami, FL 33186

Repackaged by:

American Health Packaging

Columbus, OH 43217

Package Label - Principal Display Panel

Package Label - Principal Display Panel

Docusate Sodium

Docusate Sodium CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62584-683
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 glycol 400
propylene glycol
sorbitol
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 NDC:62584-683-11 10 in 1 BLISTER PACK
2 NDC:62584-683-01 10 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-11-08


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