Label: FLEET- mineral oil enema
- NDC Code(s): 0132-0556-40
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 15, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
Ask a doctor or pharmacist before use if you have
- abdominal pain
- Nausea or vomiting
- noticed a sudden change is bowel habits lasting for longer than 2 weeks
- are pregnant or breastfeeding
When using this product
- do not take it within 2 hours of other medicines
- it may take 2 to 15 minutes to have a bowel movement
- overuse or extended use may cause dependence for bowel function
Stop use and ask a doctor if
- rectal bleeding occurs
- symptoms last for more than 7 days. This may be a sign of serious condition.
- abdominal pain
- Keep out of reach of children.
- Other information
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
mineral oil enema
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0556 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL 100 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0556-40 130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/01/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/01/2002 Labeler - C.B. Fleet Company, Inc. (003119054)