- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
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
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
-
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 dayChildren 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 dayChildren 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 dayChildren under 6 years (Up to 47 lbs) Ask a doctor (not intended for use in children under 6 years old - INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GADAVYT LOPERAMIDE HCL
loperamide hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53113-657 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 1 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) GLYCERIN (UNII: PDC6A3C0OX) SUCRALOSE (UNII: 96K6UQ3ZD4) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY (Cherry) , MINT (Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53113-657-04 1 in 1 CARTON 1 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2013 Labeler - Gadal Laboratories Inc (841305639)