Label: FLEET- glycerin suppository
- NDC Code(s): 0132-0075-00, 0132-0075-12, 0132-0075-24, 0132-0075-50
- 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 April 23, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For rectal use only.
Do not use
laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
Ask a doctor before
using any laxative if you
- have a sudden change in bowel habits lasting more than 2 weeks
- already used a laxative for more than 1 week
- have a sudden change in bowel habits lasting more than 2 weeks
-
Directions
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 consult a doctor
Insert suppository well up into rectum, to produce laxative action. Suppository is designed to dissolve only partially, which may not be noticeable.
- Other information
- Inactive ingredients
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INGREDIENTS AND APPEARANCE
FLEET
glycerin suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0075 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:0132-0075-00 100 in 1 JAR; Type 0: Not a Combination Product 11/01/1984 2 NDC:0132-0075-12 12 in 1 JAR; Type 0: Not a Combination Product 11/01/1984 3 NDC:0132-0075-24 24 in 1 JAR; Type 0: Not a Combination Product 11/01/1984 4 NDC:0132-0075-50 50 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 Labeler - C.B. Fleet Company, Inc. (003119054)