FDA Label for Gadavyt Loperamide Hcl
View Indications, Usage & Precautions
Gadavyt Loperamide Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Gadal Laboratories Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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