Stimulant Laxative
FDA Label NDC 72476-845

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Retail Business Services, Llc for the product Stimulant Laxative (NDC 72476-845). 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, purpose, indications & usage, warnings, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Purpose

Stimulant Laxative

Indications & Usage

Uses

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

Warnings

Do not use if you cannot swallow without chewing
Ask a doctor before use if you have
■ stomach pain, nausea or vomiting
■ a sudden change in bowel habits that lasts more than 2 weeks
When using this product
■ do not chew or crush tablet(s)
■ it may cause stomach discomfort, faintness and
cramps
■ do not use within 1 hour after taking an antacid
or milk

Stop Use And Ask A Doctor If


■ you have rectal bleeding or no bowel movement
after using this product. These could be signs of
a serious condition.
■ you need to use a laxative for more than 1 week

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 1(800) 222-1222.

Dosage & Administration

  • take with a glass of water
  • adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
  • children 6 to under 12 years: take 1 tablet in a single daily dose
  • children under 6 years: ask a doctor

Inactive Ingredients

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Questions Or Comments?

1-888-333-9792

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GENTLE LAXATIVE

BISACODYL 5 mg

GENTLE YET EFFECTIVE STIMULANT LAXATIVE

25 TABLETS

ENTERIC COATED

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