Senna Tabs Tablet, Film Coated
FDA Label NDC 16103-363

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc. for the product Senna Tabs (NDC 16103-363). 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, stop use and ask a doctor if, 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.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Sennosides 8.6mg

Purpose

Laxative

Uses

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

Do Not Use

For more than one week unless directed by a doctor

Ask A Doctor Before Use If You

  • have abdominal pain, nausea, or vomiting
  • are taking mineral oil
  • noticed a sudden change in bowel habits that last over 2 weeks

Stop Use And Ask A Doctor If

  • you have no bowel movement within 12 hours
  • you have rectal bleeding
    • 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

  • do not exceed recommended dose
    • Age
    		Starting Dose
    		Maximum Dose
    adults and children 12 years of age and older
    		2 tablets once a day preferably at bedtime; increase if needed, or as directed by a doctor
    		4 tablets twice a day, in the morning and at bedtime
    children under 12 years
    		ask a doctor
    		ask a doctor

Other Information

  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • each tablet contains: calcium 20 mg, potassium 70 mg
  • store at room temperature 

Inactive Ingredients:

Croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil

Questions?

Adverse drug event call: (866) 562-2756

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