FDA Label for Loperamide Hydrochloride
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 MG BLISTER CARTON (4 X 6'S TABLETS)
Loperamide Hydrochloride Product Label
The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals 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.
Drug Facts
Active ingredient (in each tablet)
Loperamide hydrochloride USP 2 mg
Purpose
Anti-diarrheal
Use
controls symptoms of diarrhea, including Travelers' Diarrhea
Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride
Heart alert: Taking more than directed can cause serious heart problems or death
Do Not Use
if you have bloody or black stool
Ask A Doctor Before Use If You Have
• fever• mucus in the stool• a history of liver disease• a history of abnormal heart rhythm
Ask A Doctor Or Pharmacist Before Use If You Are
taking a prescription drug. Loperamide may interact with certain prescription drugs.
When Using This Product
tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Stop Use And Ask A Doctor If
• symptoms get worse• diarrhea lasts for more than 2 days• you get abdominal swelling or bulging. These may be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
• drink plenty of clear fluids to help prevent dehydration caused by diarrhea• find right dose on chart. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and over | 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours |
children 9 to 11 years (60 to 95 lbs) | 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours |
children 6 to 8 years (48 to 59 lbs) | 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours |
children 2 to 5 years (34 to 47 lbs) | ask a doctor |
children under 2 years (up to 33 lbs) | do not use |
Other Information
• store at 20° to 25°C (68° to 77°F).• do not use if carton or blister unit is open or torn• Meets USP dissolution test 2• See side panel for lot number and expiration date
Inactive Ingredients
colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate
Questions Or Comments?
call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Made in India
Code .: TS/DRUGS/22/2009
Relabeled By: Preferred Pharmaceuticals Inc.
Package Label-Principal Display Panel - 2 Mg Blister Carton (4 X 6'S Tablets)
AUROHEALTH
Preferred Pharmaceuticals Inc.
NDC 68788-8393-
*Compare to the active
ingredient of Imodium® A-D
Loperamide Hydrochloride
Tablets USP 2 mg
Anti-Diarrheal
Controls the symptoms of diarrhea
24 Tablets
* Please review the disclaimer below.