Label: PEDIA-LAX- sodium phosphate, dibasic and sodium phosphate, monobasic enema
- NDC Code(s): 0132-0202-20
- 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 June 26, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Use
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Warnings
For rectal use only.
Dosage Warning:
Using more than one enema in 24 hours can be harmful.
Do not use without asking a doctor:
- for more than 3 days
- if your child has a kidney disease
- if your child has heart problems
- if your child is dehydrated
Ask a doctor before using any laxative if your 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
- for more than 3 days
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Directions
Single Daily Dosage (per 24 hours)
Do not use more per day unless directed by a doctor. See Warnings.
Do not use if child is taking another sodium phosphates product.Age Dose children 5 to 11 years 1 bottle per day or as directed by doctor children 2 to under 5 years one-half bottle per day (see below) children under 2 years DO NOT USE One-half bottle preparation:
Unscrew cap and remove 2 tablesppons of liquid with a measuring spoon. Replace cap and follow “How to use this enema” directions. -
Other information
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each 59-mL delivered dose contains: sodium 2.2g
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additional liquids by mouth are recommended while taking this product
- this product usually produces a bowel movement in 1-5 minutes
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BOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET® EMBLEM IS TORN, DAMAGED, OR MISSING, DO NOT USE
- for complete professional use, warnings and precautions, consult the Reference Safety Information on our website
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each 59-mL delivered dose contains: sodium 2.2g
- Inactive Ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PEDIA-LAX
sodium phosphate, dibasic and sodium phosphate, monobasic enemaProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0132-0202 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3.5 g in 66 mL sodium phosphate, monobasic (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37, PHOSPHATE ION - UNII:NK08V8K8HR) sodium phosphate, monobasic 9.5 g in 66 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0132-0202-20 66 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 05/10/2002 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/10/2002 Labeler - C.B. Fleet Company, Inc. (003119054)