Senna-s Tablet
FDA Label NDC 0761-0910

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Basic Drugs, Inc. for the product Senna-s (NDC 0761-0910). 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, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Docusate Sodium 50mg

Sennosides from Senna Concentrate 8.6mg

Uses

  • relieves ocasional constipation (irregularity)
  • generally produces bowel movement in 6-12 hours.

Warnings

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
    • a sudden change in bowel movements that persists over a period of 2 weeks

      • Stop use and ask a doctor if

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

        • If pregnant or breast-feeding, ask a health professional before use.

Directions

  • take only by mouth
  • 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 of age and over2 tablets once a day

    4 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 years of ageask a doctorask a doctor

Other Information

  • each tablet contains: calcium 6mg, sodium 3mg
  • store between 15° - 30°C (59° - 86°F)

Inactive Ingredients

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

Questions?

937-898-4010

Package Label.Principal Display Panel

01b_df1_senna-s.jpg (01b Df1 Senna S)

01b_df1_senna-s.jpg (01b Df1 Senna S)

01b_df2_senna-s.jpg (01b Df2 Senna S)

01b_df2_senna-s.jpg (01b Df2 Senna S)

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