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Loperamide hydrochloride and Simethicone (loperamide hydrochloride and simethicone tablet) Dailymed


Generic: loperamide hydrochloride and simethicone is used for the treatment of Colonic Diseases, Functional Constipation Diarrhea Dysentery, Bacillary Enterocolitis, Pseudomembranous Escherichia coli Infections Hemorrhage Salmonella Infections Flatulence


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Drug Facts

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

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.

OTC - WHEN USING SECTION


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.
  • you have difficulty swallowing the caplet

OTC - PREGNANCY OR BREAST FEEDING SECTION


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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
  • 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 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 years to 11 years (60 lbs to 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 years to 8 years (48 lbs to 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 years to 5 years (34 lbsto 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 between 20° to 25°C (68° to 77°F). Protect from light.

Inactive Ingredients


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

Questions Or Comments?


call toll-free 1-888-235-2466


***All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium ® Multi-Symptom Relief

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured for:

BIONPHARMA

600 Alexander Road,

Princeton, NJ 08540

MADE IN INDIA

Rev # 09/19

L0000000

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*** Compare to the active ingredients in Imodium ® Multi-Symptom Relief

NDC 69452-210-04

Loperamide HCl and Simethicone Tablets, 2 mg/125 mg

Antidiarrheal/Anti-gas

Multi-Symptom Relief

Caplet

Relieves symptoms of diarrhea plus
  • Cramps & Pressure
  • Bloating
  • Gas

Actual Size

6 Caplets*

*Capsule-shaped Tablets



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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