Loperamide Hydrochloride
FDA Label NDC 17856-0618

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Atlantic Biologicals Corps for the product Loperamide Hydrochloride (NDC 17856-0618). 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, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each 5 mL teaspoonful)

Loperamide HCl 1 mg

Purpose

Antidiarrheal

Uses

  • controls the symptoms of diarrhea, including Traveler's Diarrhea

Warnings

Do not use if you have ever had a rash or other allergic reaction to loperamide HCl Alergy alert:

if you have bloody or black stool Do not use

Ask a doctor before use if you have

  • high fever (greater than 101°F)
  • mucus present in your stool
  • a history of liver disease

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

    diarrhea lasts for more than 2 days Stop use and ask a doctor if

    , ask a health professional before use If pregnant or breast-feeding

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • use enclosed dosage cup to accurately measure dosage as noted below
  • drink plenty of clear fluids to help prevent dehydration, which may accompany diarrhea
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
    • adults and children 12 years and older4 teaspoonfuls (1 dosage cup) after the first loose bowel movement; 2 teaspoonfuls (1/2 dosage cup) after each subsequent loose bowel movement; but no more than 8 teaspoonfuls a day
    children 9-11 years (60-95 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 6 teaspoonfuls a day
    children 6-8 years (48-59 lbs)2 teaspoonfuls (1/2 dosage cup) after the first loose bowel movement; 1 teaspoonful (1/4 dosage cup) after each subsequent loose bowel movement; but no more than 4 teaspoonfuls a day
    children under 6 years (up to 47 lbs)ask a doctor (not intended for use in children under 6 years old)

Other Information

  • avoid excess heat
  • store at room temperature, 15° - 30°C (59° - 86°F)

Inactive Ingredients

alcohol (0.5%), benzoic acid, cherry flavor, glycerin, mint flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucrose. Citric acid may be used to adjust pH

Questions Or Comments?

Call 1-800-262-9010

Mon. - Thurs. 9:00 am - 4:30 pm EST,

Fri. 9:00 am - 2:30 pm EST

Serious side effects associated with use of this product may be reported to this number.



Manufactured by:

Hi-Tech Pharmacal Co., Inc.

Amityville, NY 11701


Rev. 618:05 4/12

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