FDA Label for Stimulant Laxative Enteric Coated
View Indications, Usage & Precautions
Stimulant Laxative Enteric Coated Product Label
The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each Tablet)
Bisacodyl 5 mg
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
* Please review the disclaimer below.