FDA.reportPublic FDA data

Laxative Pills

Manufacturer
Cardinal Health (Leader) 70000
Effective date
2025-06-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:36:49

Label at a glance#

ProductLaxative Pills Maximum Strength
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

swallow tablet(s) with a glass of water swallow tablet(s) whole, do not crush, break, or chew   adults and children 12 years of age and older   take 2 tablets once or twice daily   children 6 to under 12 years of age   take 1 tablet once or twice daily   children under 6 years of age   ask a doctor

Storage and handling

each tablet contains : calcium 40 mg very low sodium store between 20-25ºC (68-77ºF)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides USP, 25 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.

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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

  • do not use for a period longer than 1 week

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

  • swallow tablet(s) with a glass of water
  • swallow tablet(s) whole, do not crush, break, or chew
  adults and children 12 years of age and older  take 2 tablets once or twice daily
  children 6 to under 12 years of age  take 1 tablet once or twice daily
  children under 6 years of age  ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 40 mg
  • very low sodium
  • store between 20-25ºC (68-77ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, calcium phosphate dihydrate*, calcium sulfate anhydrous*, carnauba wax, colloidal silicon dioxide, corn starch*, croscarmellose sodium, FD&C blue #1 aluminum lake, iron oxide*, iron oxide black, iron oxide yellow*, kaolin*, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone*, shellac, stearic acid*, sugar, talc, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO EX-LAX® MAXIMUM STRENGTH active ingredient*

Maximum Strength

Laxative

Sennosides USP, 25 mg

Stimulant Laxative

Gentle

Overnight

TABLETS

†This product is not manufactured or distributed by GlaxoSmiothKline pic, distributor of ex-lax®.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGN OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

 

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Maximum Strength Laxative
LEADER Maximum Strength Laxative

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0386-1EA - Each70000-0386f49172ca-52db-41c8-837d-226039f4234a12019-03-12

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
70000-038670000-0386-1

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 PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
KAOLIN24H4NWX5COIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MALTODEXTRIN7CVR7L4A2DIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
SHELLAC46N107B71OIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

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
2e011770-374c-48a0-9e85-0b44c4ff90ee61c9ac3c-8d65-4b29-ba21-8eefbd72b3a92025-06-17WarningsExact identifier
spl id: 2e011770-374c-48a0-9e85-0b44c4ff90ee
spl set id: 61c9ac3c-8d65-4b29-ba21-8eefbd72b3a9

Reported adverse events (FAERS/openFDA)#

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