Active Ingredient (In Each Piece)
Sennosides, 15 mg
Leader Regular Strength Chocolate Laxative Sennosides Tablet
FDA Label NDC 70000-0477
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 Leader Regular Strength Chocolate Laxative Sennosides (NDC 70000-0477). 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 ingredient (in each piece), purpose, uses, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 6 to 12 hours
Otc - Do Not Use
Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
Otc - Ask Doctor
Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.
Otc - When Using
When using this product do not use for a period longer than 1 week
Otc - Stop Use
Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, 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 (1-800-222-1222) right away.
Directions
| adults and children 12 years of age and older | chew 2 chocolated pieces once or twice daily |
| children 6 to under 12 years of age | chew 1 chocolated piece once or twice daily |
| children under 6 years of age | ask a doctor |
Other Information
- each piece contains: potassium 10 mg
- store at 15°-25°C (59°-77°F)
Inactive Ingredients
cocoa powder, hydrogenated vegetable oils (palm, palm kernel), salt, soy lecithin (an emulsifier), sugar, vanilla, and whey powder (milk)
Questions Or Comments?
1-877-586-7979
Principal Display Panel – Chocolated Laxative Carton Label
LEADER™
NDC 70000-0477-1
Regular Strength
Chocolated
Laxative
Sennosides, USP, 15 mg | Stimulant Laxative
Chocolate
Flavored
Relieves Occasional
Constipation
24 pieces
Actual Size
COMPARE TO
ex•lax®
REGULAR
STRENGTH
active ingredient*
100% Money
Back Guarantee
* Please review the disclaimer below.
