Senna S Tablet
FDA Label NDC 10135-669

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 Senna S (NDC 10135-669). 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)

Docusate Sodium 50mg Sennosides 8.6 mg

Purpose

Stool softener Stimulant laxative

Uses

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

Do Not Use

  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • stomach pain
  • Nausea
  • Vomiting
  • a sudden change in bowel movements that persists over 2 weeks

Stop Use And Ask A Doctor If

you have rectal bleeding or fail to have a bowel movement after use if a laxative. These could be signs of 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
  • if you do not have a comfortable bowel movement by the second day, increase does by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable
  • agestarting dosagemaximum dosage
    adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
    children 6 to 12 years1 tablet once a day2 tablets twice a day
    children 2 to 6 years1/2 tablet once a day1 tablet twice a day
    children under 2 yearsask a doctorask a doctor

Other Information

  • each tablet contains: calcium 4mg, sodium 8mg
  • store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°30°C (59°-86°F)

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid, titanium dioxide

*Compare to the active ingredients in SENOKOT-S®

Principal Display Panel

NDC 10135-0669-01
Senna S
100 TABLETS

Principal Display Panelndc 10135-0669-01senna S100 Tablets (Senna S 01)

Principal Display Panelndc 10135-0669-01senna S100 Tablets (Senna S 01)

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