NDC 53113-101 Gadavyt

NDC Product Code 53113-101

NDC CODE: 53113-101

Proprietary Name: Gadavyt 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.

Product Characteristics


NDC Code Structure

  • 53113 - Gadal Laboratories Inc

NDC 53113-101-10

Package Description: 296 mL in 1 BOTTLE, GLASS

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Gadavyt with NDC 53113-101 is a product labeled by Gadal Laboratories Inc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1052760.

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.

  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Gadal Laboratories Inc
Labeler Code: 53113
Start Marketing Date: 10-01-2012 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients


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Gadavyt Product Label Images

Gadavyt 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

Otc - Active Ingredient

Active Ingredient                          PurposeMagnesium citrate 1.745g per fl. Oz...... Saline Laxative

Otc - Purpose

  • Usesrelieves occasional constipation (irregularity)generally produces bowel movement in 1/2 to 6 hours


  • WarningsAsk a doctor before use if you havekidney diseasea magnesium restricted dieta sodium restricted dietstomach pain, nausea or vomitingnoticed a sudden change in bowel habits that lasts more than 1 week.Ask a doctor or pharmacist before use if you arepresently taking a prescription drugWhen using this productdo not exceed the maximum recommended daily dosage in a 24 hour period

Otc - Do Not Use

  • Stop use and ask a doctor ifyou have rectal bleeding or no bowel movement after use. These could be signs of a serious conditionyou need to use a laxative for more than 1 week

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a health professional before use.

Dosage & Administration

Directionsadults and children 12 years of age and older1/2 to 1 bottle (10 fl. oz.) Drink a full 8 oz glass of liquid with each dose. These dose may be taken as a single daily dose or in divided doseschildren 6 to under 12 years of age1/3 to 1/2 bottle with a fill 8 oz glass of liquidchildren under 6 years of ageconsult a doctor

Indications & Usage

  • Other informationeach fluid once contains: sodium 36 mg, magnesium 199 mgstore at room temperatureprotect from excessive heat and freezingdiscard unused product within 24 hours of opening

Inactive Ingredient

Inactive ingredientscitric acid, flavors, purified water, red 40, saccharin sodium, sodium bicarbonate

Otc - Questions

Questions or comments?(305) 382-3288Gadal Laboratories IncMiami Fl 33186

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