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| Product NDC Code | 0132-0075 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Fleet |
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| Type | Brand | ||||||||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | RECTAL | ||||||||||
| Dosage Form | SUPPOSITORY | ||||||||||
| RxCUI drug identifier | 104155 | ||||||||||
| Application Number | part334 | ||||||||||
| Labeler Name | C.B. Fleet Company, Inc. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each suppository) Glycerin 2 g
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) adults and children 6 years and over 1 suppository or as directed by a doctor children 2 to under 6 years use Fleet® Pedia-Lax™ Suppositories children under 2 years consult a doctor Insert suppository well up into rectum, to produce laxative action. Suppository is designed to dissolve only partially, which may not be noticeable.
| adults and children 6 years and over | 1 suppository or as directed by a doctor |
| children 2 to under 6 years | use Fleet® Pedia-Lax™ Suppositories |
| children under 2 years | consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients aloe vera leaf, edetate disodium, purified water, sodium hydroxide, stearic acid
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.Uses for relief of occasional constipation this product usually produces bowel movement in ¼ to 1 hour
Purpose
Information about the drug product’s indications for use.Purpose Hyperosmotic laxative
Spl product data elements
Usually a list of ingredients in a drug product.Fleet Glycerin GLYCERIN GLYCERIN ALOE EDETATE DISODIUM WATER SODIUM HYDROXIDE STEARIC ACID
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 glycerin suppositories 12 Adult Suppositories Fleet® Laxative glycerin suppositories 12 Adult Suppositories
Principal Display Panel Fleet® Glycerin Laxative suppositories 24 adult suppositories Fleet® Glycerin Laxative suppositories 24 adult suppositories
Principal Display Panel Fleet® Glycerin Laxative suppositories 50 adult suppositories Fleet® Glycerin Laxative suppositories 50 adult suppositories
Principal Display Panel Fleet® Glycerin Laxative suppositories 100 adult suppositories Fleet® Glycerin Laxative suppositories 100 adult suppositories
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 any laxative if you 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 laxative products 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 • Store container tightly closed • Keep away from excessive heat • Mouth of jar sealed for safety. If foil imprinted with green Fleet® emblem is missing or torn, do not use.
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 using this product and consult a doctor if you have rectal bleeding no bowel movement within 1 hour of using this product These symptoms may indicate a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product rectal discomfort or burning sensation may occur.
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. Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor. Ask a doctor before using any laxative if you have a sudden change in bowel habits lasting more than 2 weeks already used a laxative for more than 1 week When using this product rectal discomfort or burning sensation may occur. Stop using this product and consult a doctor if you have rectal bleeding no bowel movement within 1 hour of using this product These symptoms may indicate a serious condition. 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