FDA.reportPublic FDA data

Laxative

Manufacturer
Cardinal Health 110, LLC. DBA Leader | LNK International, Inc.
Effective date
2026-03-12
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:49:56

Label at a glance#

ProductLaxative
Active ingredientSENNOSIDES
Label structure9 sections

Indications and uses

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

Dosage and administration

do not take more than directed 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

Storage and handling

each tablet contains: calcium 45 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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides USP, 15 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • for a period longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • 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 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 45 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0443-1

Regular Strength
Laxative

Sennosides USP, 15 mg
Stimulant Laxative

Gentle, Dependable
Constipation Relief

30 TABLETS

Actual Size

COMPARE TO
ex•lax® REGULAR
STRENGTH
active ingredient*

100% Money
Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Haleon CH SARL, owner of the
registered trademark ex•lax® Regular Strength.  50844  REV0824B34708

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

© 2025 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.

100% Money Back Guarantee
Return to place of purchase.

Leader 44-347
Leader 44-347

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200162sennosides 15 MG Oral TabletPSN12
200162sennosides, USP 15 MG Oral TabletSCD12

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295136258GTIN-13: 0096295136258
EAN-13: 0096295136258
GTIN-12: 096295136258
UPC-A: 096295136258
GTIN storage (14 digits): 00096295136258		leader-44-347-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0443-1Laxative2 in 1 CARTONTABLET, SUGAR COATED212
70000-0443-1Laxative15 in 1 BLISTER PACKTABLET, SUGAR COATED1512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0443-1EA - Each70000-044327c9404d-8862-4c53-af58-9be9809cb74612019-08-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-044370000-0443-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
SENNOSIDES3FYP5M0IJXACTIB
ACACIA5C5403N26OIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LaxativeSENNOSIDESCardinal Health 110, LLC. DBA Leader33a5d4f9-9e5a-4392-8599-ed4319cf5ff42026-03-12WarningsExact identifier
ndc (package): 70000-0443-1
ndc (product): 70000-0443
ndc11 (package): 70000044301
spl id: d665e475-64da-45b2-be11-9f55e72f9987
spl set id: 33a5d4f9-9e5a-4392-8599-ed4319cf5ff4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.