FDA.reportPublic FDA data

Laxative

Manufacturer
Bi-Mart | LNK International, Inc.
Effective date
2025-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:24

Label at a glance#

ProductLaxative Regular Strength
Active ingredientSENNOSIDES
Label structure9 sections

Indications and uses

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

Dosage and administration

swallow tablets with a glass of water swallow tablets 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

TAMPER EVIDENT: DO NOT USE IF SEAL AROUND TABLET IS BROKEN OR DAMAGED each tablet contains: calcium 35 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

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

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 any other 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 bindicate 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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • swallow tablets with a glass of water
  • swallow tablets whole; do not crush, break, or chew
adults and children 12 years of age and olderTake 2 tablets once or twice daily
children 6 to under 12 years of ageTake 1 tablet once or twice daily
children under 6 years of ageAsk a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF SEAL AROUND TABLET IS BROKEN OR DAMAGED
  • each tablet contains:calcium 35 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, calcium carbonate, carnauba wax, corn starch, dicalcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, maltodextrin**, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide.       **may contain this ingredient

Questions?

OTC - QUESTIONS SECTION

call toll-freee 1-844-912-4012

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
200162sennosides 15 MG Oral TabletPSN1
200162sennosides, USP 15 MG Oral TabletSCD1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-214-45LaxativeRegular Strength15 in 1 BLISTER PACKTABLET, SUGAR COATED151
37835-214-45LaxativeRegular Strength3 in 1 CARTONTABLET, SUGAR COATED31

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
37835-21437835-214-45

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
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
SENNOSIDES3FYP5M0IJXACTIB

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
3c3b6077-a968-212d-e063-6294a90ab40580780753-780d-4de8-b769-0e89809615fe2025-08-01WarningsExact identifier
spl id: 3c3b6077-a968-212d-e063-6294a90ab405
spl set id: 80780753-780d-4de8-b769-0e89809615fe

Reported adverse events (FAERS/openFDA)#

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