Senna-s
FDA Label NDC 68210-4103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Senna-s (NDC 68210-4103). 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 other, active ingredients (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients (In Each Tablet)

Docusate sodium 50 mg
Sennosides 8.6 mg

Purpose

Stool Softner 

Laxative

Uses

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

Warnings

Warnings

Do Not Use

  • If you are now 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 lasts over a period of 2 weeks

Otc - Stop Use

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may indicate a serious condition. 

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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 of age or 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 19.92 mg, sodium 5.61 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C yellow No. 10, FD&C Yellow No. 6, hypromellose,magnesium stearate, microcrystalline cellulose, maltodextrin,polyethylene glycol-400, purified water, sodium benzoate, stearic acid, titanium dioxide 

Questions Or Comments?

1-888-333-9792 

Pdp

Cabinet:

Stool Softener & Laxative

DOCUSATE SODIUM 50 mg

SENNOSIDES 8.6 mg

75 TABLETS

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