Imodium Advanced Caplets and Chewable Tablets (McNeil Consumer)

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DESCRIPTION

Each easy to swallow caplet and mint-flavored chewable tablet of Imodium® Advanced contains loperamide HCl 2 mg/simethicone 125 mg.

ACTIONS

Imodium® Advanced combines original prescription strength Imodium® to control the symptoms of diarrhea plus simethicone to relieve bloating, pressure and cramps commonly referred to as gas. Loperamide HCl acts by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. Simethicone acts in the stomach and intestines by altering the surface tension of gas bubbles enabling them to coalesce, thereby freeing and eliminating the gas more easily by belching or passing flatus.

USE

Controls symptoms of diarrhea plus bloating, pressure, and cramps commonly referred to as gas.

DIRECTIONS

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• find right dose on chart. If possible, use weight to dose; otherwise use age

WARNINGS

Allergy alert:    Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use if you have bloody or black stool

Ask a doctor before use if you have

· fever · mucus in the stool · a history of liver disease

Ask a doctor or pharmacist before use if you are taking antibiotics

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.

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 (1-800-222-1222) right away.

Other Information:

Caplets:

• store between 20-25°C (68-77°F)
• protect from light
• see bottom panel for expiration date and lot number

Blister statement:

• Carton: do not use if carton is open or if blister unit is open or torn
• Pouch: do not us if pouch is opened

Bottle statement:

• do not use if carton is open or if printed foil seal under bottle cap is open or torn

Chewable Tablets:

• Carton: do not use if carton is opened or if blister unit is broken
• Pouch: do not use if pouch is opened
• store between 20-25°C (68-77°F)
• see side panel for expiration date and lot number

PROFESSIONAL INFORMATION :
OVERDOSAGE INFORMATION

Overdosage of loperamide HCl in man may result in constipation, CNS depression and nausea. A slurry of activated charcoal administered promptly after ingestion of loperamide hydrochloride can reduce the amount of drug which is absorbed. If vomiting occurs spontaneously upon ingestion, a slurry of 100 grams of activated charcoal should be administered orally as soon as fluids can be retained. If vomiting has not occurred, and CNS depression is evident, gastric lavage should be performed followed by administration of 100 gms of the activated charcoal slurry through the gastric tube. In the event of overdosage, patients should be monitored for signs of CNS depression for at least 24 hours. Children may be more sensitive to central nervous system effects than adults. If CNS depression is observed, naloxone may be administered. If responsive to naloxone, vital signs must be monitored carefully for recurrence of symptoms of drug overdose for at least 24 hours after the last dose of naloxone. No treatment is necessary for the simethicone ingestion in this circumstance.

INACTIVE INGREDIENTS

Caplets: acesulfame K, cellulose, dibasic calcium phosphate, flavor, sodium starch glycolate, stearic acid Chewable Tablets: cellulose acetate, corn starch, D&C Yellow No. 10, dextrates, FD&C Blue No. 1, flavors, microcrystalline cellulose, polymethacrylates, saccharin sodium, sorbitol, stearic acid, sucrose, tribasic calcium phosphate.

HOW SUPPLIED

Mint Chewable Tablets in 6's, 12's, 18's, 30's, and blister packaging which is tamper evident and child resistant. Each Imodium® Advanced tablet is round, light green in color and has "IMODIUM" embossed on one side and "2/125" on the other side. Imodium Advanced Caplets are available in blister packs of 12's and 18's and bottles of 30's and 42's. Each Imodium® Advanced Caplet is oval, white color and has "IMO" embossed on one side and "2/125" on the other side.

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