Loperamide Hydrochloride and Simethicone LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE IMO-GEN LABS LLC FDA Approved USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
FunFoxMeds box
Substance Dimethicone
Route
ORAL
Applications
ANDA211438
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT(S) (in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg
Inactive Ingredients
INACTIVE INGREDIENTS acesulfame potassium croscarmellose sodium dibasic calcium phosphate microcrystalline cellulose stearic acid and vanilla flavor
Strengths
2 mg 125 mg
Treats Conditions
Use S Relieves Symptoms Of Diarrhea Plus Bloating Pressure And Cramps Commonly Referred To As Gas
Pill Appearance
Shape: capsule Color: white Imprint: H;L21

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0860010278123
UNII
92RU3N3Y1O 77TI35393C
Packaging

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg IBS-10 label

Package Descriptions
  • Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg IBS-10 label

Overview

USE(S) relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

Indications & Usage

USE(S) 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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours children 9-11 years (60-95 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours children 6-8 years (48-59 lbs) 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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

Warnings & Precautions
WARNINGS Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride 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 tablet If pregnant or breast-feeding , ask a health professional before use. 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) 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 tablet 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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