Loperamide Hydrochloride and Simethicone LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE GRANULES INDIA LTD FDA Approved Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
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Substance Dimethicone
Route
ORAL
Applications
ANDA215981
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Loperamide HCl 2 mg Simethicone 125 mg
Inactive Ingredients
Inactive Ingredients acesulfame potassium anhydrous dibasic calcium phosphate colloidal silicon dioxide croscarmellose sodium flavor microcrystalline cellulose stearic acid. Questions or comments? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST Manufactured by: Granules India Limited Hyderabad-500 081 INDIA MADE IN INDIA
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: I;9

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0362207739696
UNII
92RU3N3Y1O 77TI35393C
Packaging

PRINCIPAL DISPLAY PANEL Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg ANTI-DIARRHEAL / ANTI-GAS Multi-Symptom Relief Caplet Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 12 Caplets * *capsule-shaped tablets foil carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg ANTI-DIARRHEAL / ANTI-GAS Multi-Symptom Relief Caplet Relieves symptoms of diarrhea plus Cramps & Pressure Bloating Gas 12 Caplets * *capsule-shaped tablets foil 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 ag 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 each caplet contains: calcium 148.40 mg, sodium 1.40 mg store between 20-25°C (68-77°F). Protect from light. for blister: do not use if blister unit is torn or broken

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

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)


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