Stool Softener And Stimulant Laxative
FDA Label NDC 70000-0442

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Stool Softener And Stimulant Laxative (NDC 70000-0442). 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, otc - active ingredient, uses, warnings, otc - do not use, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

*This product is not manufactured or distributed by Purdue
Products L.P., owner of the registered trademark Colace® 2-IN-1.


© 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of Cardinal Health. All other
marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Made in India

All LEADER™ Brand Products Have A
Return to place of purchase if not satisfied.
100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION

Otc - Purpose

Purpose
Stool softener
Stimulant Laxative

Otc - Active Ingredient

Active ingredients
(in each softgel) 
Docusate sodium 50 mg
Sennosides 8.6 mg

Uses

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

Warnings

Warnings

Otc - Do Not Use

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 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 (1800-222-1222) 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 of age or over take 2-4 softgels daily
     children 6 to under 12 years of age       take 1-2 softgels daily
     children 2 to under 6 years of age    take upto 1 softgel daily
     children under 2 ask a doctor

Other Information

  • each softgel contains: calcium 2 mg and sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed

Inactive Ingredients

Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel - 60 Capsule Bottle Carton

Leader™

NDC 70000-0442-1

Stool
Softener +
Stimulant
Laxative

Docusate Sodium, 50 mg
Sennosides, 8.6 mg

COMPARE TO
COLACE®
2-IN-1
active ingredients*

100% Money
Back Guarantee

60 SOFTGELS 

Actual Size

* Please review the disclaimer below.