Docusate Sodium: Package Insert / Prescribing Information - Drugs.com

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# Docusate Sodium

Package insert / prescribing information
Dosage form: capsule, liquid filled
Drug class: Laxatives

Medically reviewed by Drugs.com. Last updated on Oct 24, 2022.

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.

## Related/similar drugs

MiraLAX, Colace, docusate, bisacodyl, senna, magnesium oxide

## 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)

American Health Packaging

## More about docusate

- Check interactions
- Compare alternatives
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- Reviews (36)
- Drug images
- Side effects
- Dosage information
- Patient tips
- During pregnancy
- Drug class: laxatives
- Breastfeeding
- En español

### Patient resources

- Drug Information

### Related treatment guides

- Constipation

Medical Disclaimer