Loperamide Hydrochloride Tablet
FDA Label NDC 85766-154

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sportpharm Llc for the product Loperamide Hydrochloride (NDC 85766-154). 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, warnings, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Keep the carton. It contains important information.

Distributed by:

Sportpharm LLC

379 Van Ness Ave 1401,

Torrance, CA 90501

Relabeled by:

Enovachem PHARMACEUTICALS

Torrance, CA 90501

Active Ingredient (In Each Caplet)

Loperamide Hydrochloride USP, 2 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 hydrochloride

Heart alert:Taking more than directed can cause serious heart problems or death

Otc - Do Not Use

Do not useif 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 aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

Otc - When Using

When using this producttiredness, 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 over

    2 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; ½ 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; ½ 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 between 20° – 25°C (68° – 77°F)
  • see side panel for lot number and expiration date
  • TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive Ingredients

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

Questions?

call 1-800-406-7984

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