Imodium Solution
FDA Label NDC 50580-134

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 50580-134). 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 7.5 ml), purpose, use, allergy alert, heart alert, otc - do not use, otc - ask doctor, 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 7.5 Ml)

Loperamide HCl 1 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

Otc - Ask Doctor

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.

Otc - Stop Use

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.
  • shake well before using
  • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
  • mL = milliliter
    • adults and children 12 years and over30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours
    children 9-11 years (60-95 lbs)15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours
    children 6-8 years (48-59 lbs)15 mL after first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 30 mL contains: sodium 16 mg
  • store between 20-25°C (68-77°F)
  • do not use if printed inner or outer neckband is broken or missing.

Inactive Ingredients

anhydrous citric acid, caramel color, D&C yellow no. 10, FD&C blue no. 1, flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, simethicone emulsion, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions Or Comments?

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

Principal Display Panel

NDC 50580-134-04

See New Warning
and Directions

Imodium®
A-D
Loperamide HCl, Anti-Diarrheal
1 mg per 7.5 mL

Anti-Diarrheal
Oral Solution

Controls the symptoms
of diarrhea

4 fl oz
(120 mL)

Mint Flavor

Principal Display Panel (Imodium 01)

Principal Display Panel (Imodium 01)

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