NDC 0132-0655 Pedia-lax

Magnesium Hydroxide

NDC Product Code 0132-0655

NDC CODE: 0132-0655

Proprietary Name: Pedia-lax What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Magnesium Hydroxide What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used for a short time to treat occasional constipation. It is a laxative (osmotic-type) that is thought to work by drawing water into the intestines, an effect that helps to cause movement of the intestines. This medication is also used to treat symptoms caused by too much stomach acid such as heartburn, upset stomach, or indigestion. It is an antacid that works by lowering the amount of acid in the stomach.

NDC Code Structure

  • 0132 - C.b. Fleet Company, Inc.

NDC 0132-0655-01

Package Description: 1 BOTTLE in 1 CARTON > 30 TABLET, CHEWABLE in 1 BOTTLE

NDC Product Information

Pedia-lax with NDC 0132-0655 is a a human over the counter drug product labeled by C.b. Fleet Company, Inc.. The generic name of Pedia-lax is magnesium hydroxide. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: C.b. Fleet Company, Inc.

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Pedia-lax Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MAGNESIUM HYDROXIDE 400 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MANNITOL (UNII: 3OWL53L36A)
  • SORBITOL (UNII: 506T60A25R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: C.b. Fleet Company, Inc.
Labeler Code: 0132
FDA Application Number: part334 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-01-2008 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Magnesium Hydroxide

Magnesium Hydroxide is pronounced as (mag nee' zee um) (hye drox' ide)

Why is magnesium hydroxide medication prescribed?
Magnesium hydroxide is used on a short-term basis to treat constipation.This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more inf...
[Read More]

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Pedia-lax Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Magnesium hydroxide 400 mg

Purpose

Saline laxative

Uses

  • For relief of occasional constipationthis product usually produces bowel movement in 1/2 to 6 hours

Ask A Doctor Before Using Any Laxative If Child Has

  • Kidney diseasea magnesium-restricted dietabdominal pain, nausea or vomitinga sudden change in bowel habits lasting more than 2 weeksconstipation continues after 1 week of use, contact your child's doctoralready used a laxative for more than 1 week

Stop Use And Consult A Doctor If Your Child Has

  • Rectal bleedingno bowel movement within 6 hours of using this productThese 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.

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.AgeStarting doseStarting Dose Maxiumm dose per day (24 hours)children 6 to under 12 years3-6 tablets6 tabletschildren 2 to under 6 years 1-3 tablets 3 tablets children under 2 yearsask a doctor

Other Information

  • each tablet contains: 170 mg of magnesiumCHILD RESISTANT CAPThe top of the bottle sealed for safety.Do not use if foil impreinted "SEALED for YOUR PROTECTION" is broken of missing.Gluten Free and Sugar Free

Inactive Ingredients

Colloidal silicon dioxide, FD&C red #40 aluminum lake, flavor, magnesium stearate, maltodextrin, mannitol, sorbitol, stearic acid, sucralose

Questions?

1-866-255-6960 or www.pedia-lax.com

* Please review the disclaimer below.