FLEET 2.5 g/5mL

Mineral Oil · LIQUID · C.B. Fleet Company, Inc.

1 Recall on Record

Plain English

FLEET is a liquid containing mineral oil at 2.5 g/5mL, taken oral. Manufactured by C.B. Fleet Company, Inc..

Key Facts

Brand Name: FLEET
Generic Name: Mineral Oil
NDC Code (Product): 0132-0400
Manufacturer: C.B. Fleet Company, Inc.
Strength: 2.5 g/5mL
Dosage Form: LIQUID
Route: ORAL
Marketing Status
Application #: M007
Marketing Start: 04/01/2024

Recall History

1 Recall on Record

Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

nausea2,900 reports

constipation2,599 reports

fatigue2,326 reports

pain2,287 reports

off label use2,267 reports

drug ineffective2,228 reports

vomiting2,124 reports

dyspnoea2,105 reports

diarrhoea1,881 reports

pneumonia1,797 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for relief of fecal impaction for relief of occasional constipation for removal of residue after barium administration This product usually produces a bowel movement in 2 to 15 minutes.

Dosage & Administration

Directions Single Daily Dosage (per 24 hours) adults and children 12 years and over 1 bottle per day children 2 to under 12 years one-half bottle children under 2 years DO NOT USE

Warnings

Warnings For rectal use only . Do not use when abdominal pain, nausea, or vomiting are present unless directed by a doctor. Ask a doctor before using this product if you have a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week Stop use and ask a doctor if you have rectal bleeding no bowel movement within 15 minutes of using this product These symptoms may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is FLEET used for?

FLEET contains Mineral Oil. It is a liquid taken oral. Consult your doctor for specific uses.

Is FLEET a controlled substance?

FLEET is not classified as a controlled substance by the DEA.

What is the generic name for FLEET?

The generic name for FLEET is Mineral Oil. There are 12 other brand versions of Mineral Oil.

What is the NDC code for FLEET 2.5 g/5mL?

The NDC (National Drug Code) for FLEET 2.5 g/5mL is 0132-0400, listed by C.B. Fleet Company, Inc..

Product NDC

0132-0400

Package NDC

0132-0400-48

Other Mineral Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)