Senna/docusate Sodium
FDA Label NDC 54868-4917

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Senna/docusate Sodium (NDC 54868-4917). 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 uses, directions, other information, inactive ingredients, questions?, principal display panel - 100 tablet bottle, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Uses

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

Directions

  • take preferably at bedtime or as directed by a doctor
  • if you do not have a comfortable bowel movement by the second day, increase dose by one tablet (do not exceed maximum dosage) or decrease dose until you are comfortable
  • agestarting dosagemaximum dosage
    adults and children 12 years and older2 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 20 mg, sodium 6 mg (LOW SODIUM)
  • store at room temperature 15° to 30°C (59° to 86°F)

Inactive Ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, tapioca starch

may contain these ingredients

, tartaric acid, titanium dioxide

Questions?

call 1-888-838-2872, weekdays, 8 AM-5 PM Eastern Time

Principal Display Panel - 100 Tablet Bottle

Principal Display Panel (100 Tablet Carton)

Principal Display Panel (100 Tablet Carton)

NDC 54868-4917-0

TAMPER-EVIDENT

Senna/Docusate Sodium Tablets
(brand of standardized senna concentrate
equivalent to 8.6 mg sennosides
and docusate sodium 50 mg)

Natural Vegetable Stimulant
Laxative And Stool Softener

100 TABLETS

Compare to active ingredients
of Senokot-S® Tablets


* Please review the disclaimer below.