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| Product NDC Code | 0132-0119 | ||||
|---|---|---|---|---|---|
| Drug Name | Fleet |
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| Type | Brand | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | ENEMA | ||||
| RxCUI drug identifier | 283100 | ||||
| Application Number | part334 | ||||
| Labeler Name | C.B. Fleet Company, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient (in each 118-mL delivered dose) Monobasic Sodium Phosphate 19 g, Saline Laxative Dibasic Sodium Phosphate 7 g, Saline Laxative
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
| 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 | |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients benzalkonium chloride, disodium EDTA, purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For relief of occasional constipation
Purpose
Information about the drug product’s indications for use.Other Information each 118-mL delivered dose contains: sodium 4.4 g additional liquids by mouth are recommended while taking this product this product generally produces a bowel movement in 1-5 minutes 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
Spl product data elements
Usually a list of ingredients in a drug product.Fleet Enema SODIUM PHOSPHATE, MONOBASIC SODIUM CATION SODIUM PHOSPHATE, DIBASIC SODIUM CATION BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Fleet Enema Six Pack Carton
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before using this product if you are 55 years or older are on a sodium-restricted diet Ask a doctor before using any laxative if you have 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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-255-6960 or www.fleetlabs.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if you have rectal bleeding no bowel movement or no liquid comes out of the rectum after 30 minutes symptoms of dehydration (feeling thirsty, dizziness, vomiting or urinating less often than normal) These symptoms may indicate a serious condition
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding Ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 you have kidney disease if you have heart problems if you are dehydrated
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API