loperamide hydrochloride

loperamide hydrochloride loperamide HCl LOPERAMIDE HYDROCHLORIDE LOPERAMIDE ANHYDROUS CITRIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED D&C YELLOW NO. 10 FD&C BLUE NO. 1 GLYCERIN MICROCRYSTALLINE CELLULOSE PROPYLENE GLYCOL WATER SODIUM BENZOATE SUCRALOSE TITANIUM DIOXIDE XANTHAN GUM DIMETHICONE, UNSPECIFIED SILICON DIOXIDE opaque, viscous

Active ingredient (in each 7.5 mL) Loperamide HCl 1 mg

Purpose Anti-diarrheal

Use controls symptoms of diarrhea, including Travelers’ Diarrhea

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 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. 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)

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 • 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.

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 • find right dose on chart. If possible, use weight to dose; otherwise use age. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 width="100%"><col width="29%"/><col width="71%"/><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>adults and children </paragraph><paragraph>12 years and over</paragraph></td><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph>30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 9-11 years </paragraph><paragraph>(60-95 lbs)</paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 6-8 years </paragraph><paragraph>(48-59 lbs)</paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL in 24 hours</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>children 2-5 years</paragraph><paragraph>(34 to 47 lbs)</paragraph></td><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>children under 2 years</paragraph><paragraph>(up to 33 lbs)</paragraph></td><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>do not use</paragraph></td></tr></tbody></table>

Other information • each 30 mL contains: sodium 15 mg • store between 20-25 ° C (68-77 ° F)

Inactive ingredients anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificial mint flavor, propylene glycol, purified water, simethicone, sodium benzoate, sucralose, titanium dioxide, xanthan gum

Questions or comments? 1-800-719-9260 Relabeled By: Preferred Pharmaceuticals Inc.

Package/Label Principal Display Panel Compare to the active ingredient in Imodium® A-D Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL Anti-Diarrheal Controls the symptoms of diarrhea Mint Flavor - Anti-Diarrheal Oral Solution 4 FL OZ (120 mL) SEE NEW WARNING AND DIRECTIONS Loperamide Hydrochloride Oral Solution 1mg/7.5mL