Label: FLEET- glycerin suppository
- NDC Code(s): 0132-0079-24
- Packager: C.B. Fleet Company, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 1, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
For rectal use only
May cause rectal discomfort or a burning sensation.
Ask a doctor before using any laxative if you have
- abdominal pain, nausea or vomiting
- a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
Stop use and consult a doctor if you have
- rectal bleeding
- no bowel movement within 1 hour of using this product
These symptoms may indicate a serious condition.
Single Daily Dosage (per 24 hours)
adults and children 6 years and over 1 suppository, or as directed by a doctor children 2 to under 6 years use Fleet® Pedia-Lax Suppositories® children under 2 years ask a doctor
Insert suppository well up into rectum. To product laxative action suppository is designed to dissolve only partially, which may not be noticeable.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0079 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 2 g Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0079-24 24 in 1 JAR; Type 0: Not a Combination Product 11/01/1984 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 11/01/1984 04/30/2023 Labeler - C.B. Fleet Company, Inc. (003119054)