Loperamide hydrochloride and Simethicone LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE BIONPHARMA INC. FDA Approved Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
FunFoxMeds box
Substance Dimethicone
Route
ORAL
Applications
ANDA213484

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Loperamide HCl USP 2 mg Simethicone USP 125 mg
Inactive Ingredients
Inactive ingredients acesulfame potassium anhydrous dicalcium phosphate colloidal silicon dioxide croscarmellose sodium microcrystalline cellulose stearic acid vanilla flavor
Strengths
2 mg 125 mg
Treats Conditions
Uses Relieves Symptoms Of Diarrhea Plus Bloating Pressure And Cramps Commonly Referred To As Gas
Pill Appearance
Shape: capsule Color: white Imprint: LS1

Identifiers & Packaging

Container Type BOX
UPC
0369452210048
UNII
92RU3N3Y1O 77TI35393C
Packaging

PRINCIPAL DISPLAY PANEL *** 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 6 Caplets - Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL *** 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 6 Caplets - Carton

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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 or pharmacist 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 get abdominal swelling or bulging. These may be signs of a serious condition. you have difficulty swallowing the caplet 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 right away. (1-800-222-1222)
Purpose

Purposes Anti-diarrheal Anti-gas

Do Not Use

Do not use if you have bloody or black stool if you have difficulty swallowing

When Using

When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop Use & Ask a Doctor

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

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)

Storage & Handling

Other information each caplet contains: calcium 155 mg, sodium 3 mg store between 20° to 25°C (68° to 77°F). Protect from light.

Questions

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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