1. Home
  2. Labeler Index
  3. Yyba Corp
  4. 73581-178
  5. Label Information: Anti-diarrheal/anti-gas Caplets

FDA Label for Anti-diarrheal/anti-gas Caplets

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PRINCIPAL DISPLAY PANEL

Anti-diarrheal/anti-gas Caplets Product Label

The following document was submitted to the FDA by the labeler of this product Yyba Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Principal Display Panel



label - label

label - label


* Please review the disclaimer below.