NDC 0132-0202 Pedia-lax

Sodium Phosphate, Dibasic And Sodium Phosphate, Monobasic

NDC Product Code 0132-0202

NDC 0132-0202-20

Package Description: 66 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Pedia-lax with NDC 0132-0202 is a a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Pedia-lax is sodium phosphate, dibasic and sodium phosphate, monobasic. The product's dosage form is enema and is administered via rectal form.

Labeler Name: C.b. Fleet Company, Inc.

Dosage Form: Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pedia-lax Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3.5 g/66mL
  • SODIUM PHOSPHATE, MONOBASIC 9.5 g/66mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Rectal - Administration to the rectum.
  • Rectal - Administration to the rectum.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: C.b. Fleet Company, Inc.
Labeler Code: 0132
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-10-2002 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Sodium Phosphate Rectal

Sodium Phosphate Rectal is pronounced as (soe' dee um) (fos' fate)

Why is sodium phosphate rectal medication prescribed?
Rectal sodium phosphate is used to treat constipation that happens from time to time. Rectal sodium phosphate should not be given to children younger than 2 years of age....
[Read More]

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Pedia-lax Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each 59-Ml Delivered Dose)

Monobasic Sodium Phosphate 9.5 g, Saline LaxativeDibasic Sodium Phosphate 3.5 g, Saline Laxative

Use

For relief of occasional constipation.

Warnings

  • For rectal use onlyDosage Warning:Using more than one enema in 24 hours can be harmful. Do not use without asking a doctor:for more than 3 daysif your child has kidney diseaseif your child has heart problemsif your child is dehydrated

Ask A Doctor Before Using This Product If The Child

  • Is on a sodium-restricted dietAsk a doctor before using any laxative if your child hasabdominal pain, nausea, or vomitinga sudden change in bowel habits lasting more than 2 weeksalready used a laxative for more than 1 week

Stop Use And Ask A Doctor If The Child Has

  • Rectal bleedingno bowel movement or no liquid comes out of the child's rectum after 30 minutessymptoms of dehydration (feeling thirsty, dizziness, vomiting or urinating less often than normal) These symptoms may indicate a serious condition.

Keep Out Of Reach Of Children To Prevent Accidental Ingestion.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Single Daily Dosage (per 24 hours)Do not use more unless directed by a doctor. See Warnings.Do not use if child is taking another sodium phosphates product. children 5 to 11 years1 bottle per day or as directed by a doctorchildren 2 to under 5 yearsone-half bottle per day (see below)children under 2 yearsDO NOT USEOne-half bottle prepararation: Unscrew cap and remove 2 tablespoons of liquid with a measuring spoon. Replace cap and follow "How to use this enema" directions.

Other Information

  • Each 59-mL delivered dose contains: sodium 2.2 g additional liquids by mouth are recommended while taking this productthis product generally produces a bowel movement in 1-5 minutesBOTTLE SEALED FOR SAFETY. IF BOTTLE WRAPPER WITH FLEET EMBLEM IS TORN, DAMAGED OR MISSING, DO NOT USEfor complete professional use warnings and precautions, consult the Reference Safety Information on our website

Inactive Ingredients

Benzalkonium chloride, disodium EDTA, purified water

Questions?

1-866-255-6960www.pedia-lax.com

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