FLEET
FLEET is an FDA drug label for the active ingredient MINERAL OIL manufactured by C.B. Fleet Company, Inc. administered by RECTAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231026.
Generic: MINERAL OIL
Manufacturer: C.B. Fleet Company, Inc.
Product Type: HUMAN OTC DRUG
Route: RECTAL
Dosage Form:
NDC: 0132-0301
Application: M007
Effective: 20231026
Active Ingredients: Active ingredient (in each 118 mL delivered dose) Mineral oil 100%
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
Contraindications
Not available.
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.
Adverse Reactions
Not available.
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