Imodium A-d Capsule, Liquid Filled
FDA Label NDC 50580-367

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 A-d (NDC 50580-367). 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 capsule), purpose, use, allergy alert, heart alert, 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 Capsule)

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

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

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.

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.

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 loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

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

Inactive Ingredients

butylated hydroxyanisole, edible ink, FD&C blue no. 1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water

Questions Or Comments?

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

Principal Display Panel

NDC 50580-367-02

See New Warning

Imodium®
A-D
Loperamide HCl, 2mg/Anti-Diarrheal
Soft Gelatin Capsules

Anti-Diarrheal
Softgels

Controls the symptoms
of diarrhea

24 Softgels*
Actual Size

Suitable for adults and
children 12 years and over

*each liquid-filled capsule contains 2 mg loperamide HCl

* Please review the disclaimer below.