Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg (OTC)
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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 |
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
INACTIVE INGREDIENTS
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor