Label: FLEET- glycerin liquid
- NDC Code(s): 0132-0185-01, 0132-0185-82
- 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 March 22, 2021
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- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each 5.4 mL average delivered dose)
- Ask a doctor before using any laxative if you
- Stop using this product and consult a doctor if you have
- Keep out of reach of children
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 Liquid Glycerin Suppositories children under 2 years ask a doctor
CAUTION: REMOVE ORANGE PROTECTIVE SHIELD BEFORE INSERTING.
Insert suppository well up into rectum. Suppository need not melt completely to produce laxative action.
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0185 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 5.4 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0185-01 1 in 1 PACKAGE; Type 0: Not a Combination Product 06/03/2002 2 NDC:0132-0185-82 4 in 1 CARTON; Type 0: Not a Combination Product 06/03/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 06/03/2002 Labeler - C.B. Fleet Company, Inc. (003119054)