Active Ingredient (In Each Suppository)
Active Ingredient (in each Suppository) Purpose
Bisacodyl USP, 10 mg.................................Laxative
Premier Value Bisacodyl Laxative
FDA Label NDC 68016-306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Consortium for the product Premier Value Bisacodyl Laxative (NDC 68016-306). 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 suppository), uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor, 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
Uses
Uses - For relief of occasional constipation -this product generally produces bowel movement in 1/4 hour to 1 hour
Warnings
For rectal use only.
Do Not Use
Do not use laxative products
-when abdominal pain, nausea, or vomiting are present - for a period longer than 1 week
Ask A Doctor Before Use If You Have
Ask a doctor before use if you have noticed a sudden change in bowel movement
burning and mild cramps
When Using This Product
When using this product it may cause abdominal discomfort, faintness, rectal burning, and mild cramps
Stop Use And Ask A Doctor
Stop use and ask a doctor if rectal bleeding occurs, or you fail to have bowel movement after using a laxative. This may indicate 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. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
-adults and children 12 years of age and older - detach one suppository from the strip
-remove from wrapper before inserting into the rectum - the rectal suppository dose is one suppository per day or as directed by a doctor - children under 12 years of age consult a doctor.
Other Information
Other information
store below 30oC (86oF)
Inactive Ingredient
Inactive ingredient
hydrogenated vegetable oil
Purpose
Active Ingredient (in each Suppository) Purpose
Bisacodyl USP, 10 mg.................................Laxative
Product Label
Product Label (Pv Bisacodyl 8ctefb)
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