FDA.reportPublic FDA data

Sennosides

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:17:34

Label at a glance#

ProductSennosides
Active ingredientSENNOSIDES
Label structure9 sections

Indications and uses

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

Dosage and administration

take preferably at bedtime or as directed by a doctor age starting dosage maximum dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years of age 1 tablet once a day 2 tablets twice a day children 2 to under 6 years of age 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SENNOSIDES 8.6mg Tablet

MarlexPharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach Pain
  • Nausea
  • Vomiting
  • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate 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

  • take preferably at bedtime or as directed by a doctor
agestarting dosagemaximum dosage
adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
children 6 to under 12 years of age1 tablet once a day2 tablets twice a day
children 2 to under 6 years of age1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

SAFE HANDLING WARNING SECTION

  • Each tablet contains: Calcium 4 mg , Sodium 3mg
  • Store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15° to 30°C (59°-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose.

*Compare to Senokot®

Product color may vary slightly due to nature of ingredients.

*Marlex Pharmaceuticals, Inc. is not affiliated with the owner of the registered trademark Senokot®.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0314-01

Sennosides

8.6 mg

100 TABLETS

314-01314-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312935sennosides 8.6 MG Oral TabletPSN14
312935sennosides, USP 8.6 MG Oral TabletSCD14
312935sennosides A and B 8.6 MG Oral TabletSY14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-314-01Sennosides1 in 1 CARTONTABLET114
10135-314-01Sennosides100 in 1 BOTTLETABLET10014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-314-01EA - Each10135-314c01e68fc-d5cc-486d-bacb-5600dc92731412019-02-13

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10135-31410135-314-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT
SENNOSIDES3FYP5M0IJXACTIB

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
SennosidesSENNOSIDESMarlex Pharmaceuticals Inc5ca287a3-c4f6-402d-978e-cd1328bdbc472025-11-21WarningsExact identifier
ndc (package): 10135-314-01
ndc (product): 10135-314
ndc11 (package): 10135031401
spl id: 441efbb5-f993-9e3c-e063-6294a90a8f29
spl set id: 5ca287a3-c4f6-402d-978e-cd1328bdbc47

Reported adverse events (FAERS/openFDA)#

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