Anti-diarrheal/anti-gas Caplets Tablet
FDA Label NDC 73581-178

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Anti-diarrheal/anti-gas Caplets (NDC 73581-178). 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 ingredients (in each caplet), purposes, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor 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 Ingredients (In Each Caplet)

Loperamide HCl, USP 2 mg

Simethicone, USP 125 mg

Purposes

Anti-diarrheal

Anti-gas

Uses

Relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

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
  • if you have difficulty swallowing

Ask A Doctor Before Use If You Have

  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm

Ask A Doctor Before Use If You Are

taking a prescription drug. Loperamide may interact with certain prescription drugs.

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 have difficulty swallowing the caplet
  • 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 (1-800-222-1222) right away.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • take only on an empty stomach (1 hour before or 2 hours after a meal)
  • take with a full (8 oz.) glass of water
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
    adults and children 12 years and over2 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

  • each caplet contains: calcium 155 mg, sodium 3 mg
  • store at 20-25°C (68-77°F)
  • protect from light

Inactive Ingredients

acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor

Questions?

call toll-free 1-866-933-6337

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