Active Ingredient (In Each Tablet)
Bisacodyl 5 mg
Stimulant Laxative Enteric Coated Tablet
FDA Label NDC 71335-1531
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bryant Ranch Prepack for the product Stimulant Laxative Enteric Coated (NDC 71335-1531). 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
Purpose
Stimulant Laxative
Uses
- relieves occasional constipation and irregularity
- generally produces a bowel movement in 6 to 12 hours
Warnings
Do not use
• for more than one week unless directed by a doctor
• if you cannot swallow without chewing
• within 1 hour after taking an antacid or milk
Ask a doctor before use if you have
• abdominal pain
• nausea
• vomiting
• a sudden change in bowel habits that lasts longer than 2 weeks
When using this product • abdominal discomfort, faintness, or cramps may occur
Stop use and ask a doctor
• if you have no bowel movement within 12 hours
• if you have rectal bleeding
• these could be signs of a serious condition
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.
Directions
• do not take more than directed
• swallow whole, do not chew or crush
• take recommended dose in a single daily dose
• take with water
• adults and children 12 years and older: take 1-3 (usually 2) tablets daily
• children 12 and under: ask a doctor
Other Information
• store at room temperature
• avoid excessive humidity
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• package not child resistant
• for institutional use only
Inactive Ingredients
Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate, Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate, Wax. May also contain: Calcium Sulfate, Gelatin, Sodium Starch Glycolate.
How Supplied
Product: 71335-1531
NDC: 71335-1531-1 30 TABLET in a BOTTLE
NDC: 71335-1531-2 2 TABLET in a BOTTLE
NDC: 71335-1531-3 3 TABLET in a BOTTLE
NDC: 71335-1531-4 4 TABLET in a BOTTLE
NDC: 71335-1531-5 10 TABLET in a BOTTLE
NDC: 71335-1531-6 90 TABLET in a BOTTLE
NDC: 71335-1531-7 8 TABLET in a BOTTLE
NDC: 71335-1531-8 100 TABLET in a BOTTLE
NDC: 71335-1531-9 20 TABLET in a BOTTLE
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