Imodium Tablet
FDA Label NDC 50580-338

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Imodium (NDC 50580-338). 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, otc - purpose, uses, allergy alert, heart alert, 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

Other

Drug Facts

Otc - Purpose

Active ingredients (in each caplet)Purposes
Loperamide HCl 2 mgAnti-diarrheal
Simethicone 125 mgAnti-gas

Uses

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

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
  • if you have difficulty swallowing

Ask A Doctor Before Use If You Have

  • fever
  • mucus in the stool
  • a history of liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking antibiotics

Otc - When Using

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 the caplet

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
  • 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 right dose on chart below. If possible, use weight to dose; otherwise, use age.
    • adults and children 12 years and over2 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

  • each caplet contains: calcium 165 mg, sodium 3 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if carton is open or if blister unit is open or torn

Inactive Ingredients

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

Questions Or Comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

See New Warning and Directions

NDC 50580-338-18

Imodium®
Loperamide HCl, 2 mg/Simethicone, 125 mg Antidiarrheal/Anti-gas

Multi-Symptom Relief
Caplet

Relieves symptoms
of diarrhea plus

  • Cramps & Pressure
  • Bloating
  • Gas

    • 18 Caplets*

    *capsule-shaped tablets
    Actual Size

    Principal Display Panel (Imodium 01)

    Principal Display Panel (Imodium 01)

* Please review the disclaimer below.