FDA Label for Loperamide Hydrochloride
View Indications, Usage & Precautions
Loperamide Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Atlantic Biologicals Corps. 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.
Active Ingredient
(in each 5 mL teaspoonful)
Loperamide HCl 1 mg
Purpose
Antidiarrheal
Uses
- controls the symptoms of diarrhea, including Traveler's Diarrhea
Warnings
Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Alergy alert:
if you have bloody or black stool Do not use
Ask a doctor before use if you have
- high fever (greater than 101°F)
- mucus present in your stool
- a history of liver disease
taking antibiotics Ask doctor or pharmacist before use if you are
diarrhea lasts for more than 2 days Stop use and ask a doctor if
, ask a health professional before use If pregnant or breast-feeding
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
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 dose 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 years (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 years (48-59 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 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) |
Other Information
- avoid excess heat
- store at room temperature, 15° - 30°C (59° - 86°F)
Inactive Ingredients
alcohol (0.5%), benzoic acid, cherry flavor, glycerin, mint flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose. Citric acid may be used to adjust pH
Questions Or Comments?
Call 1-800-262-9010
Mon. - Thurs. 9:00 am - 4:30 pm EST,
Fri. 9:00 am - 2:30 pm EST
Serious side effects associated with use of this product may be reported to this number.
Manufactured by:
Hi-Tech Pharmacal Co., Inc.
Amityville, NY 11701
Rev. 618:05 4/12
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