Country: United States
Language: English
Source: NLM (National Library of Medicine)
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)
American Sales Company
ORAL
OTC DRUG
Anti-diarrheal controls symptoms of diarrhea, including Travelers’ Diarrhea
Abbreviated New Drug Application
CAREONE DIARRHEA CONTROL- LOPERAMIDE HCL SUSPENSION AMERICAN SALES COMPANY ---------- AMERICAN SALES COMPANY DIARRHEA CONTROL DRUG FACTS ACTIVE INGREDIENT (IN EACH 7.5 ML) Loperamide HCl 1 mg PURPOS E Anti-diarrheal US E 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 • • • • 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 STOP USE AND ASK A DOCTOR IF • • • IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. fever mucus in the stool a history of liver disease a history of abnormal heart rhythm tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) DIRECTIONS • • • • • 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 OTHER INFORMATION • • INACTIVE INGREDIENTS anhydrous citric acid, carboxymethylcellulose sodium, D&C yellow no. 10, FD&C blue no. 1, glycerin, microcrystalline cellulose, natural and artificia Read the complete document