FDA Label for Stool Softener And Stimulant Laxative
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- OTC - ACTIVE INGREDIENT
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL - 60 CAPSULE BOTTLE CARTON
Stool Softener And Stimulant Laxative Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.