Otc - Active Ingredient
Active ingredient (in each tablet)
Bisacodyl 5 mg
Gentle Laxative
FDA Label NDC 67091-385
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods Llc for the product Gentle Laxative (NDC 67091-385). 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 - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Stimulant laxative
Indications & Usage
Uses
• relieves occasional constipation and irregularity
• this product generally produces bowel movement in 6 to 12 hours
Warnings
Warnings
Otc - Do Not Use
Do not use if you cannot swallow without chewing
Otc - Ask Doctor
Ask a doctor before use if you have
• stomach pain, nausea or vomiting
• a sudden change in bowel habits that lasts more than 2 weeks
Otc - When Using
When using this product
• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk
• you may have stomach discomfort, faintness or cramps
Otc - Stop Use
Stop use and ask a doctor if
• you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
• you need to use a laxative for more than 1 week
Otc - Pregnancy 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. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- take with a glass of water
| adults and children 12 years and over | take 1 to 3 tablets in a single daily dose |
| children 6 to under 12 years of age | take 1 tablet in a single daily dose |
| children under 6 years of age | ask a doctor |
Other Safety Information
Other Information
•
each tablet contains: magnesium 5 mg
• store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
• use by expiration date on package
• protect from excessive humidity
Inactive Ingredient
Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
Otc - Questions
Comments & Questions? 800-824-1706
Package Label.Principal Display Panel
014r-winco-gentle-lax-carton-label-24s (014r Winco Gentle Lax Carton Label 24s)
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