Laxative Senna Tablet, Coated
FDA Label NDC 36800-984

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Laxative Senna (NDC 36800-984). 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 other, active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY TOPCO
ASSOCIATES LLC, ELK GROVE
VILLAGE, IL 60007

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

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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 over2 tablets once a day4 tablets twice a day
    children 6 to under 12 years1 tablet once a day2 tablets twice a day
    children 2 to under 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 27.93 mg, magnesium 0.19 mg
  • store between 20-25 °C (68-77 °F)

Inactive Ingredients

crosscarmellose sodium, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, silicon dioxide, talc, triacetin

Questions Or Comments

Call: 1-888-577-8033

Principal Display Panel - 100 Mg Tablet Bottle Carton

*Compare to SENOKOT®,
Active ingredient
NDC 36800-165-01

Vegetable
Laxative

Sennosides 8.6 mg

  • Laxative
  • Gentle, Overnight relief of
    constipation

    • 100
    TABLETS

    Principal Display Panel (100 mg Tablet Bottle Carton)

    Principal Display Panel (100 mg Tablet Bottle Carton)

* Please review the disclaimer below.