Active Ingredient (In Each Tablet)
Sennosides USP, 15 mg
Laxative Tablet, Sugar Coated
FDA Label NDC 70000-0443
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 110, Llc. Dba Leader for the product Laxative (NDC 70000-0443). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, 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
Do Not Use
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
Ask A Doctor Before Use If You Have
noticed a sudden change in bowel habits that persists over a period of 2 weeks.
Ask A Doctor Or Pharmacist Before Use If You Are
are taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.
When Using This Product
do not use for a period longer than 1 week.
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.
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 (1-800-222-1222) right away.
Directions
- swallow tablet(s) with a glass of water
- swallow tablet(s) whole; do not crush, break, or chew
| adults and children 12 years and over | 2 tablets once or twice daily |
| children 6 to under 12 years | 1 tablet once or twice daily |
| children under 6 years | ask a doctor |
Other Information
- each tablet contains: calcium 45 mg, magnesium 5 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive Ingredients
acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide
Questions Or Comments?
1-800-426-9391
Principal Display Panel
LEADER™
NDC 70000-0443-1
Regular Strength
Laxative
Sennosides USP, 15 mg
Stimulant Laxative
Gentle Overnight
Relief
30 TABLETS
COMPARE TO
ex•lax® REGULAR
STRENGTH
active ingredient*
100% Money
Back Guarantee
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
*This product is not manufactured or distributed by GSK group of
companies, owner of the registered trademark ex•lax® Regular Strength.
©2018 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.
50844 ORG031734701
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
100% Money Back Guarantee
Return to place of purchase.
Leader 44-347 (Leader 44 347 1)
* Please review the disclaimer below.
