MedPath

Laxative

Approved
Approval ID

80780753-780d-4de8-b769-0e89809615fe

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

Bi-Mart

DUNS: 027630078

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sennosides

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code37835-214
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Sennosides
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (24)

ACACIAInactive
Code: 5C5403N26O
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SENNOSIDESActive
Quantity: 15 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/13/2025

Principal display panel

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/13/2025

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/13/2025

Active ingredient (in each tablet)

Sennosides 15 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/13/2025

Purpose

Stimulant Laxative

WARNINGS SECTION

LOINC: 34071-1Updated: 8/13/2025

Warnings

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 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

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 bindicate a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/13/2025

Directions

  • 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 SECTION

LOINC: 44425-7Updated: 8/13/2025

Other information

*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 INGREDIENT SECTION

LOINC: 51727-6Updated: 8/13/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/13/2025

Questions?

call toll-freee1-844-912-4012

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Laxative - FDA Drug Approval Details