NDC 0132-0119 Fleet

Enema

NDC Product Code 0132-0119

NDC 0132-0119-46

Package Description: 133 mL in 1 BOTTLE, WITH APPLICATOR

NDC Product Information

Fleet with NDC 0132-0119 is a a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Fleet is enema. 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.

Fleet 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, MONOBASIC 19 g/133mL
  • SODIUM PHOSPHATE, DIBASIC 7 g/133mL

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.

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

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: 05-26-2011 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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Fleet 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 118-Ml Delivered Dose)

Monobasic Sodium Phosphate 19 g, Saline LaxativeDibasic Sodium Phosphate 7 g, Saline Laxative

Use

For relief of occasional constipation

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 daysif you have kidney diseaseif you have heart problemsif you are dehydrated

Ask A Doctor Before Using This Product If You

  • Are 55 years or olderare on a sodium-restricted dietAsk a doctor before using any laxative if you haveabdominal 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 You Have

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

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Keep Out Of Reach Of Children

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 taking another sodium phosphates product. adults and children 12 years and over 1 bottle per day children 2 to 11 years Use Fleet Pedia-Lax Enema children under 2 years DO NOT USE

Other Information

  • Each 118-mL delivered dose contains: sodium 4.4 gadditional 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 USE.for complete professional use warnings and precautions, consult the Reference Safety Information on our website

Inactive Ingredients

Benzalkonium chloride, disodium EDTA, purified water

Questions?

1-866-255-6960 or www.fleetlabs.com

* Please review the disclaimer below.