Senna Tablet
FDA Label NDC 82568-0006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Senna (NDC 82568-0006). 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 drug facts, purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active ingredient (in each tablet)

Sennosides 8.6 mg

Purpose

Laxative

Uses

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

Warnings

Do not use

  • laxative products for longer than one 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 care professional before use.

Directions

take preferably at bedtime or as directed by a doctor

agestarting dosagemaximum 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 of age

ask a doctor

ask a doctor

Inactive Ingredients

microcrystaline cellulose, dicalcium phosphate, sodium starch glycolate, croscarmellose sodium, hypromellose, povidone, collodial silicon dioxide, megnesium stearate. 

Other

Tamper Evident:

Do not use if imprinted inner safety seal is torn or missing.

This product is not manufactured or distributed by Purdue Products L.P.,

Owner of the registered trademark Senokot ®

Manufactured for:

Aarna USA Inc.

Leland, NC 28451

Package Label.Principal Display Panel

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