Other
Drug Facts
Keep the carton. It contains important information.
Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
R0319
Loperamide Hydrochloride
FDA Label NDC 67296-1906
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Redpharm Drug for the product Loperamide Hydrochloride (NDC 67296-1906). 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 other, active ingredient (in each caplet), purpose, use, warnings, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Caplet)
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
Otc - Do Not Use
Do not useif 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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.
Otc - When Using
When using this producttiredness, 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours |
children 9-11 years (60-95 lbs) | 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours |
children 6-8 years (48-59 lbs) | 1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours |
children 2-5 years (34 to 47 lbs) | ask a doctor |
children under 2 years (up to 33 lbs) | do not use |
Other Information
- store between 20° – 25°C (68° – 77°F)
- see side panel for lot number and expiration date
- TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
Inactive Ingredients
anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
Questions?
call 1-800-406-7984
Principal Display Panel
NDC 51660-123-06
†Compare To
the active ingredient of
Imodium
®A-D
See New Warnings
and Directions
ohm ®
Loperamide Hydrochloride
Tablets USP, 2 mg
Anti-Diarrheal
Controls the symptoms of diarrhea
6 Caplets*
Each caplet (*capsule-shaped tablet) contains Loperamide Hydrochloride USP, 2 mg
†Ohm ®is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.
Ohm Loperamide 6 Count Blister Carton (Loperamide 01)
* Please review the disclaimer below.
