Senna
FDA Label NDC 17856-6289

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Senna (NDC 17856-6289). 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 teaspoonful), purpose, uses, ask a doctor before use if you have, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Teaspoonful)

Sennosides 8.8 mg

Purpose

Laxative

Uses

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

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 - Do Not Use

Do not use laxative products for longer than 1 week unless directed by a doctor

Otc - Keep Out Of Reach Of Children

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

Directions

Take preferably at bedtime or as directed by a doctor. Shake Well Before Using.

agestarting dosemaximum dosage
adults and children 12 years and older2 - 3 teaspoons once a day3 teaspoons twice a day
children 6 to under 12 years1 - 1 1/2 teaspoons once a day1 1/2 teaspoons twice a day
children 2 to under 6 years1/2 - 3/4 teaspoon once a day3/4 teaspoon twice a day
children under 2 yearsask a doctorask a doctor

Other Information

  • avoid excessive heat
  • store at room temperature 15°- 30°C (59°- 86°F)

Inactive Ingredients

cocoa distillate flavor, natural chocolate flavor, methylparaben, propylene glycol, propylparaben, purified water, sucrose

Questions?

To Report Adverse Drug Event Call (800) 616-2471

Other

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