Senna And Docusate Sodium
FDA Label NDC 11534-090

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sunrise Pharmaceutical Inc for the product Senna And Docusate Sodium (NDC 11534-090). 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, indications and usage, warnings, otc - ask a doctor before use if you have, otc - stop use and ask a doctor if, otc – if pregnant or breast feeding, otc - 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

Otc - Active Ingredient

Docusate sodium 50 mg

Sennosides 8.6 mg

Otc - Purpose

Stool softener and Stimulant laxative

Indications And Usage

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement within 6 to 12 hours

Warnings

Do not use:

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so by a doctor

Otc - Ask A Doctor Before Use If You Have

  • Stomach pain
  • Nausea
  • Vomiting
  • Noticed a sudden change in bowel habits that lasts over 2 weeks

Otc - Stop Use And Ask A Doctor If

You have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

Otc – If Pregnant Or Breast Feeding

Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

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

Dosage And Administration

  • Take preferably at bedtime or as directed by a doctor
    • agestarting dosagemaximum dosage
    adults and children 12 years  of age or older2 tablets once a day4 tablets twice a day
    children 6 to under 12 years  1 tablet once a day2 tablets twice a day
    children 2 to under 6 years ½ tablet once a day1 tablet twice a day
    children under 2 years ask a doctorask a doctor

Other Information

  • Each tablet contains: calcium 30 mg, sodium 3 mg VERY LOW SODIUM
  • Do not use if imprinted safety seal under cap is missing or damaged.
  • Store at 25° C (77° F); excursions permitted between 15° C-30° C (59° -86° F).
  • Keep tightly closed.

Inactive Ingredient

Colloidal silicon dioxide, dicalcium phosphate, D&C yellow No 10 Aluminum Lake, ethanol, FD&C yellow No 6 Aluminum Lake, hydroxypropyl methyl cellulose, magnesium stearate, microcrystalline cellulose, mineral oil,  polyethylene glycol, pregelatinized starch, silicon dioxide, sodium benzoate, stearic acid, talc, titanium dioxide

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