Gadavyt
FDA Label NDC 53113-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gadal Laboratories Inc for the product Gadavyt (NDC 53113-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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

Otc - Purpose

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

Warnings

Warnings

Ask a doctor before use if you have

  • kidney disease
  • a magnesium restricted diet
  • a sodium restricted diet
  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that lasts more than 1 week.
    • Ask a doctor or pharmacist before use if you are
    • presently taking a prescription drug
      • When using this product
      • do not exceed the maximum recommended daily dosage in a 24 hour period

Otc - Do Not Use

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after use. These could be signs of a serious condition
  • you 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

Directions

adults and children 12 years of age and older
1/2 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 doses
children 6 to under 12 years of age
1/3 to 1/2 bottle with a fill 8 oz glass of liquid
children under 6 years of age
consult a doctor

Indications & Usage

Other information

  • each fluid once contains: sodium 36 mg, magnesium 199 mg
  • store at room temperature
  • protect from excessive heat and freezing
  • discard unused product within 24 hours of opening

Inactive Ingredient

Inactive ingredients

citric acid, flavors, purified water, red 40, saccharin sodium, sodium bicarbonate

Otc - Questions

Questions or comments?

(305) 382-3288

Gadal Laboratories Inc

Miami Fl 33186

Package Label.Principal Display Panel

Magcitcherry (Magcitcherry)

Magcitcherry (Magcitcherry)

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