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Docusate Sodium

Dosage Form: capsule, liquid filled

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active ingredient (in each capsule)

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

Docusate Sodium 
Docusate Sodium capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG 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) Docusate Sodium 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 red (Reddish) Score no score
Shape OVAL Size 12mm
Flavor Imprint Code SCU1
Contains     
Packaging
# Item Code Package Description
1 NDC:62584-683-01 100 BLISTER PACK in 1 CARTON
1 NDC:62584-683-11 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/08/2010 04/30/2017
Labeler - American Health Packaging (929561009)
Establishment
Name Address ID/FEI Operations
SWISS CAPS USA, INC. 033105888 manufacture(62584-683)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 repack(62584-683)
Revised: 11/2015
 
American Health Packaging
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