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| Product NDC Code | 0132-0202 | ||||
|---|---|---|---|---|---|
| Drug Name | Pedia-lax |
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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 | 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 Ingredients (in each 59-mL delivered dose) Monobasic Sodium Phosphate 9.5 g................ Dibasic Sodium Phosphate 3.5 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) Do not use more per day unless directed by a doctor. See Warnings . Do not use if child is taking another sodium phosphates product. Age Dose children 5 to 11 years 1 bottle per day or as directed by doctor children 2 to under 5 years one-half bottle per day (see below) children under 2 years DO NOT USE One-half bottle preparation: Unscrew cap and remove 2 tablesppons of liquid with a measuring spoon. Replace cap and follow “How to use this enema” directions.
| Age | Dose |
| children 5 to 11 years | 1 bottle per day or as directed by doctor |
| children 2 to under 5 years | one-half bottle per day (see below) |
| 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.
Purpose
Information about the drug product’s indications for use.Purpose Saline laxative Saline laxative
Spl product data elements
Usually a list of ingredients in a drug product.Pedia-Lax 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 Pedia-Lax Sodium Phosphates Saline Enema 2.25 fl oz (66 mL) PRINCIPAL DISPLAY PANEL Pedia-Lax Sodium Phosphates Saline Enema 2.25 fl oz (66 mL)
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.PEDIA-LAX sodium phosphates Saline Enema C.B. Fleet Company, Inc. ---------- 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 the child is on a sodium-restricted diet
Ask a doctor before using any laxative if your child has 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 to prevent accidental ingestion. If swallowed, get medical help or contact a Poison Control Center 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 59-mL delivered dose contains : sodium 2.2g additional liquids by mouth are recommended while taking this product this product usually 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
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 www.pedia-lax.com Fleet ® Enemas are LATEX-FREE
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 your child has a kidney disease if your child has heart problems if your child is dehydrated Ask a doctor before using this product if the child is on a sodium-restricted diet Ask a doctor before using any laxative if your child has 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 Stop use and ask a doctor if your child has rectal bleeding no bowel movement or no liquid comes out of the child’s rectum after 30 minutes symptoms of dehydration [feeling thirsty, dizziness, vomiting, 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.
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