Imodium Tablet, Film Coated
FDA Label NDC 50580-317

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 50580-317). 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, allergy alert, heart alert, otc - do not use, ask a doctor before use if you have, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient (In Each Caplet)

Loperamide HCl 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

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

Otc - Do Not Use

Do not use if 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 are taking a prescription drug. Loperamide may interact with certain prescription drugs.

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.

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 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; 1/2 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; 1/2 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 at 20°-25°C (68°-77°F)
  • do not use if blister unit is broken or torn

Inactive Ingredients

anhydrous lactose, carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch

Questions Or Comments?

1-877-895-3665 (toll-free) or215-273-8755 (collect)

Principal Display Panel

NDC 50580-317-06

Imodium®
A-D

Loperamide Hydrochloride Tablets, 2mg
Anti-Diarrheal

Anti-Diarrheal
Caplets

Controls the symptoms
of diarrhea

Actual Size

*Capsule-Shaped Tablets

12 Caplets*

Principal Display Panel (Imodium 01)

Principal Display Panel (Imodium 01)

* Please review the disclaimer below.