Loperamide Hydrochloride and Simethicone

Loperamide Hydrochloride and Simethicone Loperamide Hydrochloride and Simethicone ACESULFAME POTASSIUM CROSCARMELLOSE SODIUM ANHYDROUS DIBASIC CALCIUM PHOSPHATE MICROCRYSTALLINE CELLULOSE STEARIC ACID LOPERAMIDE HYDROCHLORIDE LOPERAMIDE DIMETHICONE DIMETHICONE H;L21

ACTIVE INGREDIENT(S) (in each tablet) Loperamide Hydrochloride USP 2 mg Simethicone USP 125 mg

PURPOSES Anti-diarrheal Anti-gas

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

WARNINGS Allergy alert: Do not use 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.

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)

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

<table cellspacing="0" cellpadding="0" border="0" width="591.6505"><col width="37.5182645835675%"/><col width="62.4817354164325%"/><tbody><tr styleCode="Botrule"><td align="justify" styleCode="Lrule Rrule" valign="top">adults and children 12 years and over </td><td align="justify" styleCode="Rrule" valign="top">2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours </td></tr><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule" valign="top"> children 9-11 years (60-95 lbs) </td><td align="justify" styleCode="Rrule" valign="top">1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours </td></tr><tr styleCode="Botrule"><td align="left" styleCode="Lrule Rrule" valign="top"> children 6-8 years (48-59 lbs) </td><td align="left" styleCode="Rrule" valign="top"> 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets in 24 hours </td></tr><tr styleCode="Botrule"><td align="justify" styleCode="Lrule Rrule" valign="top">children 2-5 years (34 to 47 lbs) </td><td align="justify" styleCode="Rrule" valign="top">ask a doctor </td></tr><tr><td align="justify" styleCode="Lrule Rrule" valign="top">children under 2 years (up to 33 lbs) </td><td align="justify" styleCode="Rrule" valign="top">do not use </td></tr></tbody></table>

OTHER INFORMATION • each tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg • store between 20 to 25°C (68 to 77°F). Protect from light. • do not use if carton is open or if blister unit is open or torn QUESTIONS OR COMMENTS call 1-888-588-1418 Manufactured for FSA Store Inc. 473 Blair Rd Suite 100 PMB 24308 Dallas, TX 75231 Customer Help Line: 1-888-588-1418

INACTIVE INGREDIENTS acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor

PRINCIPAL DISPLAY PANEL Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-6's foil loperamidesimethiconecarton loperamidesimethiconefoil