Gadavyt Loperamide Hcl
FDA Label NDC 53113-657

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 Loperamide Hcl (NDC 53113-657). 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, indications & usage, warnings, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, dosage & administration, 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 (in each 5mL teaspoonful)            Purpose

Loperamide HCl, 1mg ....................................................Antidiarrheal

Otc - Purpose

Purpose

Antidiarrheal

Indications & Usage

Uses

controls the symptoms of diarrhea, including Traveler's Diarrhea.

Warnings

Warnings

Allergy Alert:Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl.

Otc - Do Not Use

Do not use if you have bloody or black stool

Ask a Doctor before use if you have

  • high fiver (greater than 101 degrees F)
  • mucus present in your stool
  • a history of liver disease
    Ask a doctor or pharmacist before use if you are taking antibiotics
    • Stop use and ask a doctor if diarrhea lasts for more than 2 days

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

Otc - Pregnancy Or Breast Feeding

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

Dosage & Administration

Directions

Use enclosed dosage cup to accurately measure dosage as noted below

  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • find right dosage on chart
  • if possible, use weight to dose; otherwise, use age.

    • Adults and children 12 years and older
    		4 teaspoonfuls (1 dosage cup) after the first loose bowel movement;
    2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement;
    but no more than 8 teaspoonfuls a day
    Children 9-11 (60-95 lbs)
    		2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement;
    1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement;
    but no more than 6 teaspoonfuls a day
    Children 6-8 (48-59 lbs)
    		2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement;
    1 teaspoonfuls (1/4 dosage cup) after each subsequent loose bowel movement;
    but no more than 4 teaspoonfuls a day
    Children under 6 years (Up to 47 lbs)
    		Ask a doctor (not intended for use in children under 6 years old

Inactive Ingredient

Inactive ingredients

citric acid, propylene glycol, methylparaben, propylparaben, glycerin, sucralose, cherry flavor, peppermint flavor, sorbitol, purified water

Otc - Questions

Questions or comments?

Call 305-382-3288

www.gadallaboratories.com

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