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| Product NDC Code | 0132-0655 | ||||
|---|---|---|---|---|---|
| Drug Name | Pedia-lax |
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| Type | Brand | ||||
| Pharm Class | Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, CHEWABLE | ||||
| RxCUI drug identifier | 790436, 1088243 |
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| 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 Ingredient (in each tablet) Magnesium hydroxide 400 mg
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 Use dosage chart for proper dosing. Doses may be taken as a single daily dose or in divided doses. Drink a full glass (8 ounces) of liquid with each dose. Age Starting dose Starting Dose Maximum dose per day (24 hours) children 6 to under 12 years 3-6 tablets 6 tablets children 2 to under 6 years 1-3 tablets 3 tablets children under 2 years ask a doctor
| Age | Starting dose | Starting Dose Maximum dose per day (24 hours) |
| children 6 to under 12 years | 3-6 tablets | 6 tablets |
| children 2 to under 6 years | 1-3 tablets | 3 tablets |
| children under 2 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, mannitol, sorbitol, stearic acid, sucralose
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 abowel movement in 1/2 to 6 hours
Purpose
Information about the drug product’s indications for use.Purpose Saline laxative
Spl product data elements
Usually a list of ingredients in a drug product.Pedia-Lax Magnesium hydroxide MAGNESIUM HYDROXIDE MAGNESIUM CATION HYDROXIDE ION SILICON DIOXIDE FD&C RED NO. 40 MAGNESIUM STEARATE MALTODEXTRIN MANNITOL SORBITOL STEARIC ACID SUCRALOSE Pedia;Lax
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 ® Magnesium hydroxide Chewable Laxative 30 chewable tablets Pedia-Lax® Magnesium hydroxide Chewable Laxative 30 chewable tablets
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 Chewable Tablets 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 child has kidney disease a magnesium-restricted diet abdominal pain, nausea or vomiting a sudden change in bowel habits lasting more than 2 weeks constipation that continues after 1 week of use, contact your child's doctor already used a laxative for more than 1 week Stop us ing this product and consult a doctor if your child has rectal bleeding does not have a bowel movement within 6 hours of using this product these symptoms maybe signs of a serious condition Keep out of reach of children . In case of overdose, get medical help or contact Poison Control Center (1-800-222-1222) right away.
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 . In case of overdose, get medical help or contact 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 tablet contains : 170 mg of magnesium CHILD RESISTANT CAP The top of the bottle sealed for safety. Do not use if foil imprinted "SEALED for YOUR PROTECTION" is broken of missing. Gluten Free and Sugar Free
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.pedia-lax.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 us ing this product and consult a doctor if your child has rectal bleeding does not have a bowel movement within 6 hours of using this product these symptoms maybe signs of 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
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