Stimulant Laxative Plus Stool Softener Tablet, Film Coated
FDA Label NDC 17856-1248

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corp. for the product Stimulant Laxative Plus Stool Softener (NDC 17856-1248). 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 active ingredients (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, 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

Active Ingredients (In Each Tablet)

Docusate Sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener

Stimulant laxative

Uses

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

Do Not Use

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so 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 2 weeks

Stop Use And Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after the use of a laxative.

These could be sings of a serious condition.

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 (1-800-222-1222).

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 over

    take 2-4 tablets daily

    children 6 to under 12 years of age

    take 1-2 tablets daily

    children 2 to under 6 years of age

    take upto 1 tablet daily

    children under 2 

    ask a doctor

Other Information

  • each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
  • store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)

Inactive Ingredients

croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

Questions Or Comments?

1-800-645-2158

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

MIAMI, FL 33179

Package Label.Principal Display Panel

NDC 17856-1248-01

Compare to the

active ingredients

in Colace® 2-IN-1*

Stimulant

Laxative

Plus Stool Softener

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

50 mg/ 8.6 mg

100 TABLETS

Image Description (17856 1248 01)

Image Description (17856 1248 01)

* Please review the disclaimer below.