Active Ingredient (In Each Tablet)
Bisacodyl USP 5mg
Bisacodyl 5mg Tablet, Coated
FDA Label NDC 69168-398
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Bisacodyl 5mg (NDC 69168-398). 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 have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant Laxative
Uses
- for relief of occasional constipation (irregularity)
- this product generally produces bowel movement in 6 to 12 hours
Do Not Use
- if you are unable to swallow without chewing
- within 1 hour after taking an antacid or milk
Ask A Doctor Before Use If You Have
- abdominal pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that persists over a period of 2 weeks
When Using This Product
- do not chew or crush tablets
- abdominal discomfort, faintness, and cramps may occur
Stop Use And Ask A Doctor If
- you need to use more than 1 week
- rectal bleeding or failure to have a bowel movement after use of a laxative.
These may be signs of a serious condition.
If Pregnant Or Breast-Feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.
Directions
- take with waterÂ
Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily
Children 6 to 12 years of age: take 1 tablet once a day
Children under 6 years of age: consult a doctor
Other Information
- store between 68° to 77°F (20° to 25°C)
- do not use blister unit is broken or torn
Inactive Ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow # 6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polyvinyl acetate pthalate, polydextrose, polyethylene glycol, propylparaben, propylene glycol, povidone, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
Principal Display Panel
Bisacodyl 5mg Pink (398 Health A2z Bisacodyl 5mg Pink 1)
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