Label: ANTI-DIARRHEAL/ANTI-GAS- loperamide hydrochloride, simethicone tablet
- NDC Code(s): 69256-265-31, 69256-265-33, 69256-265-73
- Packager: Harris Teeter, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 5, 2025
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENTS (in each caplet)Loperamide HCl 2 mg - Simethicone 125 mg
-
PURPOSEAnti-diarrheal - Anti-gas
-
USE(S)relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
-
WARNINGSAllergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl - Heart alert: Taking more than directed can cause serious heart problems or death
-
DO NOT USEif you have bloody or black stool - if you have difficulty swallowing
-
ASK A DOCTOR BEFORE USE IF THE CHILD HASfever - mucus in the stool - a history of liver disease - a history of abnormal heart rhythm
-
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU AREtaking a prescription drug. Loperamide may interact with certain prescription drugs.
-
WHEN USING THIS PRODUCTtiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
-
STOP USE AND ASK DOCTOR IFsymptoms get worse - diarrhea lasts for more than 2 days - you get abdominal swelling or bulging. These may be signs of a serious condition. you have difficulty swallowing the caplet
-
IF PREGNANT OR BREAST FEEDING,ask a health professional before use.
-
KEEP OUT OF REACH OF CHILDRENIn case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
-
DIRECTIONSdrink plenty of clear fluids to help prevent dehydration caused by diarrhea - take only on an empty stomach (1 hour before or 2 hours after a meal) take with a full (8 oz.) glass of water - find ...
-
OTHER INFORMATIONeach 10 mL contains: calcium 180 mg, sodium 3 mg - store between 20-25°C (68-77°F). Protect from light. do not use if blister unit is torn or broken
-
INACTIVE INGREDIENTSacesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid
-
QUESTIONS OR COMMENTSCall 1-609-860-2600 (Monday-Friday 8 am- 4 pm)
-
PRINCIPAL DISPLAY PANELHarris Teeter™ NDC 69256-265-31 - MULTI-SYMPTOM RELIEF - ANTI-DIARRHEAL/ANTI-GAS - Loperamide Hydrochloride and Simethicone - Tablets, 2 mg/125 mg - Relieves Symptoms of ...
-
INGREDIENTS AND APPEARANCEProduct Information