Laxative Docusate Sodium With Senna Tablet, Coated
FDA Label NDC 36800-861

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Laxative Docusate Sodium With Senna (NDC 36800-861). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredients (in each tablet)Purposes
Docusate sodium 50 mgStool softener
Sennosides 8.6 mgStimulant laxative

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

Do Not Use

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Otc - Stop Use

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
    • adults and children 12 years and overtake 2-4 tablets daily
    children 6 to under 12 years of agetake 1-2 tablets daily
    children 2 to under 6 years of agetake up to 1 tablet daily
    children under 2 yearsask a doctor

Other Information

  • each tablet contains: calcium 20 mg, sodium 3 mg (low sodium)
  • store between 20-25°C (68-77°F)

Inactive Ingredients

colloidal silicon dioxide, crosscarmellose sodium, dibasic calcium phosphate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

Questions?

Call 1-888-423-0139

Principal Display Panel - 100 Tablet Bottle Carton

NDC 36800-154-01

*Compare to the active ingredients
in Colace® 2-IN-1

Stool
Softener
+ Stimulant
Laxative

DOCUSATE SODIUM 50 mg
STOOL SOFTENER

SENNOSIDES 8.6 mg
STIMULANT LAXATIVE

For Relief of
Occasional Constipation

  • Effective
  • Reliable
  • Comfortbale

    • 100 TABLETS

    actual size

    Principal Display Panel (100 Tablet Bottle Carton)

    Principal Display Panel (100 Tablet Bottle Carton)

* Please review the disclaimer below.