Leader Regular Strength Chocolate Laxative sennosides

Manufacturer
CARDINAL HEALTH | Aphena Pharma Solutions MD, LLC
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:48:36

Label at a glance#

ProductLeader Regular Strength Chocolate Laxative sennosides
Active ingredientSennosides
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient (in each piece)

OTC - ACTIVE INGREDIENT SECTION

Sennosides, 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

OTC - DO NOT USE SECTION

Do not use laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor

OTC - ASK DOCTOR SECTION

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 SECTION

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 SECTION

When using this product do not use for a period longer than 1 week

OTC - STOP USE SECTION

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 SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

  • each piece contains: potassium 10 mg
  • store at 15°-25°C (59°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocoa powder, hydrogenated vegetable oils (palm, palm kernel), salt, soy lecithin (an emulsifier), sugar, vanilla, and whey powder (milk)

Questions or comments?

OTC - QUESTIONS SECTION

1-877-586-7979

Principal Display Panel – Chocolated Laxative Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Principal Display Panel – Chocolated Laxative Carton Label
Principal Display Panel – Chocolated Laxative Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251020sennosides 15 MG Chewable TabletPSN5
251020sennosides, USP 15 MG Chewable TabletSCD5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0477-12023-02-17C16284748780-1f386c64a-252a-0266-e053-dadaa90a7c1aDrug Facts
70000-0477-12023-01-30C16284748780-1f386c64a-252a-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0477-1Leader Regular Strength Chocolate Laxative sennosides2 in 1 CARTONTABLET25
70000-0477-1Leader Regular Strength Chocolate Laxative sennosides12 in 1 POUCHTABLET125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0477LEADER REGULAR STRENGTH CHOCOLATE LAXATIVE SENNOSIDES (SENNOSIDES) TABLET [CARDINAL HEALTH ]5Current NDC, Legacy NDC, 2 package rows20241226_1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0477-1EA - Each70000-04770606b77b-e0be-4248-b1ef-bad92c54635112019-08-06

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-047770000-0477-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Sennosides3FYP5M0IJXACTIB
CocoaD9108TZ9KGIACT

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
Leader Regular Strength Chocolate Laxative sennosidesSENNOSIDESCARDINAL HEALTH1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e2024-12-23WarningsExact identifier
ndc (package): 70000-0477-1
ndc (product): 70000-0477
ndc11 (package): 70000047701
spl id: 31e8abf8-2096-4ada-addb-160aeae03f3d
spl set id: 1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e

Reported adverse events (FAERS/openFDA)#

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