Label: PEDIA-LAX- glycerin suppository
- NDC Code(s): 0132-0081-12
- 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.
Drug Label Information
Updated April 23, 2020
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- Active Ingredient
- Purpose
- Uses
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Warnings
For rectal use only
May cause rectal discomfort or a burning sensation.
Ask a doctor before using any laxative if child has
- 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
- abdominal pain, nausea or vomiting
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEDIA-LAX
glycerin suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0081 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 1 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:0132-0081-12 12 in 1 JAR; Type 0: Not a Combination Product 03/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part334 03/01/2008 Labeler - C.B. Fleet Company, Inc. (003119054)