Senna-s Tablet, Film Coated
FDA Label NDC 63561-0187

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Granulation Technology, Inc. for the product Senna-s (NDC 63561-0187). 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 drug facts, active ingredients (in each tablet), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop using and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients (In Each Tablet)

Docusate Sodium         50 mg

Sennosides                        8.6 mg

Purpose

Stool softener

Laxative

Uses

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 hours

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 continues over a period of 2 weeks

Stop Using 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.

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 (1-800-222-1222) right away.

Directions

  • Take preferably at bedtime or as directed by a doctor
    • agestarting dosagemaximum dosage
    adults and children
    12 years of age and over     		2 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 30 mg, Sodium 6 mg LOW SODIUM
  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

croscarmellose sodium,dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, FD&C red 40 lake, FD&C yellow 5 lake

Principal Display Panel

NDC 63561-0187-2

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

220 Film-Coated Tablets

Docusate Sodium 50 mg Sennosides 8.6 mg (Senna S)

Docusate Sodium 50 mg Sennosides 8.6 mg (Senna S)

Docusate Sodium 50 mg Sennosides 8.6 mg_peel (Senna S 2)

Docusate Sodium 50 mg Sennosides 8.6 mg_peel (Senna S 2)

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