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| Product NDC Code | 0132-0400 | ||||
|---|---|---|---|---|---|
| Drug Name | Fleet |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 1489229 | ||||
| Application Number | M007 | ||||
| Labeler Name | C.B. Fleet Company, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each 5 mL / teaspoonful) Mineral Oil 2.5 mL.......................................
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive i ngredients acacia, benzoic acid, carrageenan (irish moss), ethyl vanillin, glycerin, mapliene triple oil, purified water, titanium dioxide, vanillin
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses ▪ relieves occasional constipation ▪ generally produces bowel movement in 6 to 8 hours
Purpose
Information about the drug product’s indications for use.Purpose Lubricant Laxative
Spl product data elements
Usually a list of ingredients in a drug product.FLEET Mineral Oil MINERAL OIL MINERAL OIL ACACIA BENZOIC ACID CARRAGEENAN ETHYL VANILLIN GLYCERIN WATER TITANIUM DIOXIDE VANILLIN
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel Fleet ® Laxative Mineral Oil Oral Liquid Lubricant Laxative 16 FL OZ (480 mL) Fleet ® Laxative Mineral Oil Oral Liquid Lubricant Laxative 16 FL OZ (480 mL)
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ▪ for children under 6 years of age, pregnant women, bedridden patients or persons with difficulty swallowing
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature 15°-25°C (59°-77°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call toll-free 1-855-727- 4277
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not take with meals.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API