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| Product NDC Code | 0132-0078 | ||||
|---|---|---|---|---|---|
| Drug Name | Fleet |
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| Type | Brand | ||||
| Pharm Class | Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC] |
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| Active Ingredients |
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| Route | RECTAL | ||||
| Dosage Form | ENEMA | ||||
| RxCUI drug identifier | 730955 | ||||
| Application Number | M007 | ||||
| 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 ingredients
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 if taking another sodium phosphates product. Do not use more unless directed by a doctor. See Warnings . adults and children 12 and over 1 bottle per day children 2 to 11 years use Fleet® Pedia-Lax® Enema children under 2 years DO NOT USE If no urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.
| adults and children 12 and over | 1 bottle per day |
| children 2 to 11 years | use Fleet® Pedia-Lax® Enema |
| children under 2 years | DO NOT USE |
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. This product usually produces a bowel movement in 1 to 5 minutes.
Purpose
Information about the drug product’s indications for use.Purpose (in each 197 mL delivered dose) Monobasic sodium phosphate 19g ... Saline laxative Dibasic sodium phosphate 7g ......... Saline laxative
Spl product data elements
Usually a list of ingredients in a drug product.Fleet sodium phosphate, dibasic and sodium phosphate, monobasic SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE PHOSPHATE ION SODIUM CATION sodium phosphate, monobasic SODIUM CATION PHOSPHATE ION EDETATE DISODIUM WATER BENZALKONIUM CHLORIDE
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.PRINCIPAL DISPLAY PANEL Fleet Laxative Saline Enema Extra Volume 1 Bottle 7.8 Fl Oz (230 mL) each PRINCIPAL DISPLAY PANEL Fleet Laxative Saline Enema Extra Volume 1 Bottle 7.8 Fl Oz (230 mL) each
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 of age or older • are on a sodium-restricted diet • have a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than 1 week
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use • for more than 3 days • if you have kidney disease • if you have heart problems • if you are dehydrated • when abdominal pain, nausea, or vomiting are present unless directed by a doctor
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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information • each 197 mL delivered dose contains: sodium 4.4 g • additional liquids by mouth are recommended while taking this product
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, urinating less often than normal] These symptoms may indicate a serious condition.
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. Using more than one enema in 24 hours can be harmful. Do not use • for more than 3 days • if you have kidney disease • if you have heart problems • if you are dehydrated • when abdominal pain, nausea, or vomiting are present unless directed by a doctor Ask a doctor before using this product if you • are 55 years of age or older • are on a sodium-restricted diet • have a sudden change in bowel habits lasting more than 2 weeks • already used a laxative for more than 1 week 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, 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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
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