Senna-s Tablet, Film Coated
FDA Label NDC 73057-378

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ulai Health Llc for the product Senna-s (NDC 73057-378). 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 ingredients (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.

Label Section Quick Index

Active Ingredients (In Each Tablet)

Sennosides 8.6 mg

Docusate Sodium 50 mg

Purpose

Laxative

Stool Softener

Uses

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

Do Not Use

  • if you are 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
  • 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 the use of a laxative.

    • These may indicate 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 (1-800-222-1222).

Directions

  • take preferably at bedtime or as directed by a doctor

    • age

    starting dosage

    maximum dosage

    adults and children 12 years and over

    2 tablets once a day 

     4 tablets twice a day

    children 6 to under 12 years

    1 tablet once a day

     2 tablets twice a day

    children 2 to under 6 years 

    1/2 tablet once a day

     1 tablet twice a day

    children under 2 years

    ask a doctor

     ask a doctor

Other Information

  • each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
  • store at 20-25°C(68-77°F); excursions permitted between 15o-30oC (59o-86oF)

Inactive Ingredients

croscarmellose sodium, D&C Yellow# 10, dicalcium phosphate, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, sodium benzoate, talc, titanium dioxide

Questions?

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

Package Label.Principal Display Panel

PHARBEST

NDC 73057-378-11

Manufactured in the USA

*Compare to the active ingredients in Senokot-S®

SENNA-S

Sennosides 8.6 mg &

Docusate Sodium 50 mg

Natural Vegetable Laxative

Ingredient Plus Stool Softener

1000 TABLETS

* Please review the disclaimer below.