Otc - Purpose
Bisacodyl (Stimulant Laxative)
Walgreens Gentle Laxative Suppository
FDA Label NDC 0363-0468
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Gentle Laxative (NDC 0363-0468). 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 - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
- for relief of occasional constipation
- this product generally produces bowel movement in 1/4 to 1 hour
Warnings
For rectal use only.
Otc - Do Not Use
Do not use
- when abdominal pain, nausea, or vomiting are present
- for a period of longer than 1 week
Otc - Ask Doctor
Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts
over a period of 2 weeks
Otc - When Using
When using this product it may cause abdominal discomfort, faintness, rectal burning and mild cramps
Otc - Stop Use
Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have a bowel movement after using this product.
This may indicate a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - 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.
Dosage & Administration
-detach one suppository from the strip
-remove wrapper before inserting into the rectum
adults and children 12 years of age and older: 1 suppository once daily
children 6 to under 12 years: 1/2 suppository once daily
children under 6 years: do not use
Storage And Handling
Store at room temperature
Do not exceed 30 C (86 F)
Lot No. & Exp. Date: see wrapper or box
Inactive Ingredient
hydrogenated vegetable oil
* Please review the disclaimer below.
