Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE- loperamide hydrochloride and simethicone tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 5, 2025

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  • ACTIVE INGREDIENT(S)
    (in each tablet) Loperamide Hydrochloride USP 2 mg - Simethicone USP 125 mg
  • PURPOSES
    Anti-diarrheal - Anti-gas
  • USE(S)
    relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
  • 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 - • if you have difficulty swallowing
  • 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 aretaking 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. • you have difficulty swallowing ...
  • PREGNANCY OR BREAST FEEDING
    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 right away. (1-800-222-1222)
  • DIRECTIONS
    •  drink 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 ...
  • OTHER INFORMATION
    • each tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg - • store between 20 to 25°C (68 to 77°F). Protect from light. • do not use if carton is open or if blister ...
  • INACTIVE INGREDIENTS
    acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
  • QUESTIONS OR COMMENTS
    call - 1-888-588-1418 - Manufactured for - FSA Store Inc.  473 Blair Rd Suite 100  PMB 24308 Dallas, TX 75231  Customer Help Line: 1-888-588-1418
  • PRINCIPAL DISPLAY PANEL
    Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton - Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil
  • INGREDIENTS AND APPEARANCE
    Product Information
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