Sennosides Tablet
FDA Label NDC 10135-314

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Sennosides (NDC 10135-314). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient (In Each Tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Do Not Use

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

Ask A Doctor Before Use If You Have

  • 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

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,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • 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

  • Each tablet contains: Calcium 4mg, 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

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid

*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

NDC 10135-0314-01
Sennosides
8.6 mg
100 TABLETS

Principal Display Panelndc 10135-0314-01sennosides8.6 mg100 Tablets (Sennosides 01)

Principal Display Panelndc 10135-0314-01sennosides8.6 mg100 Tablets (Sennosides 01)

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