Senna-s
FDA Label NDC 67046-670

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Contract Pharmacy Services-pa for the product Senna-s (NDC 67046-670). 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 tablet), purpose, uses, do not use, ask a doctor before use if you have, stop use and ask a doctor if you have, 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.

Active Ingredient (In Each Tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

Stool softener & Stimulant laxative

Uses

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

Do Not Use

  • this product if you are presently taking mineral oil, unless directed by a doctor
  • laxative products for more than 1 week unless directed by a doctor

Ask A Doctor Before Use If You Have

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that persists over 2 weeks

Stop Use And Ask A Doctor If You Have

  • have rectal bleeding
  • fail to have a bowel movement after the use of a laxative
  • These could be signs of 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.

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 dosemaximum dose
    adults and children 12 years and over2 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)
  • TAMPER-EVIDENT: Do not use this product if foil seal on back of blister is cut, torn, broken or missing
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-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 starch1, tartaric acid1, titanium dioxide

1may contain these ingredients

Questions Or Comments?

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

Distributed by:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960 Dist. 1999 0110REV 89
192B R1009

Repackaged by:

Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA

Original--08/2010--NJW

* Please review the disclaimer below.