Loperamide Hydrochloride Solution
FDA Label NDC 41250-813

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer Distribution Inc for the product Loperamide Hydrochloride (NDC 41250-813). 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 active ingredient (in each 7.5 ml), purpose, use, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 7.5 Ml)

Loperamide HCl 1 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

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking antibiotics

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. (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 over

    30 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 the 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 the 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 15 mg
  • store between 20-25°C (68-77°F)

Inactive Ingredients

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

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to Imodium® A-D active ingredient

MINT FLAVOR

loperamide hydrochloride oral solution, 1 mg per 7.5 mL

Anti-Diarrheal

SEE NEW WARNINGS AND DIRECTIONS

Controls the Symptoms of Diarrhea

4 FL OZ (120 mL)

Anti-Diarrheal

Oral Solution

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