Senokot Tablet, Film Coated
FDA Label NDC 67618-120

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Senokot (NDC 67618-120). 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 otc - active ingredient, otc - purpose, otc - when using, warnings, otc - do not use, otc - ask doctor, 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

Otc - Active Ingredient

Drug Facts

Active ingredient (in each tablet) Purpose

Sennosides 17.2 mg

Otc - Purpose

Purpose

Laxative

Otc - When Using

Uses

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

Warnings

Warnings

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements 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.

Dosage & Administration

Directions

  • take preferably at bedtime or as directed by a doctor

Dosage Forms & Strengths

agestarting dosagemaximum dosage
adults and children 12 years of age and over1 tablet once a day2 tablets twice a day
children 6 to under 12 years1/2 tablet once a day1 tablet twice a day
children under 6 ask a doctorask a doctor

Otc - Questions

Other information

  • each tablet contains: calcium 20 mg
  • store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F)

Inactive Ingredient

Inactive ingredients croscarmellose sodium, dicalcium phosphate, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, mineral oil, stearic acid, talc, tartaric acid

©2017, Purdue Products L.P.

Dist. by: Purdue Products L.P., Stamford, CT 06901-3431

304214-0B

Package Label.Principal Display Panel

Senokot® Extra Strength
NDC: 67618-120-12

* Please review the disclaimer below.