Label: ANTI-DIARRHEAL- loperamide hydrochloride capsule, liquid filled

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

Drug Label Information

Updated April 7, 2025

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  • Active ingredient (in each capsule)
    Loperamide HCl 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 HCl - Heart alert:Taking more than directed can cause serious heart problems or death
  • Do not use
    if you have bloody or black stool - in children under 12 years of age
  • 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 right away.
  • Directions
    drink plenty of clear fluids to help prevent dehydration caused by diarrhea. not for use in children under 12 years of age - adults and children 12 years and over: 2 softgels after the first ...
  • Other information
    store at 20°-25°C (68°-77°F). Protect from Light. avoid excessive heat above 40°C (104°F) do not use if carton or blister unit is open or torn - see side panel for lot number and expiration ...
  • Inactive ingredients
    butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water
  • Questions or comments?
    call toll free - 1-888-235-2466(Mon - Fri 9AM - 5PM EST)
  • SPL UNCLASSIFIED SECTION
    THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. LOVE IT - OR IT'S ...
  • Carton
    NDC 21130-835-12 - COMPARE TO - the active ingridient - in Imodium - ® A-D - ƚ Signatue - SELECT - ® ANTI-DIARRHEAL - LOPERAMIDE HCl CAPSULES, 2 mg - Controls the symptoms of diarrhea ...
  • INGREDIENTS AND APPEARANCE
    Product Information