Active Ingredient (In Each 5 Ml/Teaspoonful)
Mineral Oil 2.5 mL.......................................
Fleet Liquid
FDA Label NDC 0132-0400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by C.b. Fleet Company, Inc. for the product Fleet (NDC 0132-0400). 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 5 ml/teaspoonful), purpose, uses, do not use, ask a doctor before using this product if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lubricant Laxative
Uses
▪ relieves occasional constipation
▪ generally produces bowel movement in 6 to 8 hours
Do Not Use
▪ for children under 6 years of age, pregnant women, bedridden patients or persons with difficulty swallowing
Ask A Doctor Before Using This Product If You Have
▪ abdominal pain, nausea or vomiting
▪ a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are
presently taking a stool softener laxative.
When Using This Product
do not take with meals.
Stop Use And Ask A Doctor If
▪ you notice rectal bleeding or fail to have a bowel movement after use of a laxative. This may indicate a serious condition. Discontinue use and consult a doctor.
▪ you need to use the product more than one week
If Breast-Feeding,
ask a health professional before use.
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 with meals
▪ shake well before using
▪ adults and children 12 years of age and over: 3 to 9 teaspoons (15 - 45 mL), maximum 9 teaspoons (45 mL) in 24 hours
▪ children 6 to under 12 years of age: 1 to 3 teaspoons (5 – 15 mL), maximum 3 teaspoons (15 mL) in 24 hours or as directed by a doctor
▪ children under 6 years of age: consult a doctor
Inactive Ingredients
acacia, benzoic acid, carrageenan (irish moss), ethyl vanillin, glycerin, mapliene triple oil, purified water, titanium dioxide, vanillin
Other Information
Store at room temperature 15°-25°C (59°-77°F)
Questions?
Call toll-free 1-855-727-4277
Principal Display Panel
Fleet ®
Laxative
Mineral Oil
Oral Liquid
Lubricant Laxative
16 FL OZ (480 mL)
Fleet ® Laxativemineral Oil Oral Liquid Lubricant Laxative 16 Fl Oz (480 mL) (Fleet Mineral Oil 0132 0400 01)
* Please review the disclaimer below.
