OTC Medication Information: Docusate Sodium
DOCUSATE SODIUM- docusate sodium capsule, liquid filled
American Health Packaging
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
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| Labeler — American Health Packaging (007914906) |
| 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: 01/2012 American Health Packaging
