signature care anti diarrheal anti gas LOPERAMIDE HYDROCHLORIDE SIMETHICONE SAFEWAY FDA Approved Uses relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
FunFoxMeds box
Substance Dimethicone
Route
ORAL
Applications
ANDA209837

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Loperamide HCl 2 mg Simethicone 125 mg
Inactive Ingredients
Inactive ingredients acesulfame potassium croscarmellose sodium dibasic calcium phosphate maltodextrin microcrystalline cellulose natural and artificial flavor propylene glycol stearic acid
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: oval Color: white Imprint: L0R1;2;125

Identifiers & Packaging

Container Type BOX
UNII
92RU3N3Y1O 77TI35393C
Packaging

Package/Label Principal Display Panel Signature care ® Compare to Imodium ® Multi-Symptom Relief active ingredients Quality Guaranteed CAPLET MULTI-SYMPTOM RELIEF Anti-Diarrheal/Anti-Gas LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, 2 mg/125 mg Anti-diarrheal/Anti-gas Actual Size Relieves symptoms of diarrhea plus • Cramps & Pressure • Bloating • Gas 24 CAPLETS* *Capsule-shaped tablets Anti-Diarrheal/Anti-Gas Carton Image 1 of 2 Anti-Diarrheal/Anti-Gas Carton Image 2 of 2

Package Descriptions
  • Package/Label Principal Display Panel Signature care ® Compare to Imodium ® Multi-Symptom Relief active ingredients Quality Guaranteed CAPLET MULTI-SYMPTOM RELIEF Anti-Diarrheal/Anti-Gas LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE TABLETS, 2 mg/125 mg Anti-diarrheal/Anti-gas Actual Size Relieves symptoms of diarrhea plus • Cramps & Pressure • Bloating • Gas 24 CAPLETS* *Capsule-shaped tablets Anti-Diarrheal/Anti-Gas Carton Image 1 of 2 Anti-Diarrheal/Anti-Gas Carton Image 2 of 2

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 9-11 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

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 165 mg, sodium 3 mg • store between 20 ° -25 ° C (68 ° -77 ° F). Protect from light. • do not use if printed blister unit is broken or torn

Questions

Questions or comments? 1-800-719-9260


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