Country: United States
Language: English
Source: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
Retail Business Services, LLC
ORAL
OTC DRUG
Acid reducer
New Drug Application
CAREONE OMEPRAZOLE- OMEPRAZOLE TABLET, DELAYED RELEASE RETAIL BUSINESS SERVICES, LLC ---------- RETAIL BUSINESS SERVICES, LLC. OMEPRAZOLE DRUG FACTS ACTIVE INGREDIENT (IN EACH TABLET) Omeprazole 20 mg PURPOSE Acid reducer USE • • WARNINGS ALLERGY ALERT: Do not use if you are allergic to omeprazole DO NOT USE IF YOU HAVE: • • • • These may be signs of a serious condition. See you doctor. ASK A DOCTOR BEFORE USE IF YOU HAVE: • • • • • ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE taking a prescription drug. Acid reducers may interact with certain prescription drugs. STOP USE AND ASK A DOCTOR IF: • • • • • 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 treats frequent heartburn (occurs _2 OR MORE_ days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with LIGHTHEADEDNESS, SWEATING OR DIZZINESS chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent CHEST PAIN had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain • • • 14-DAY COURSE OF TREATMENT • • • • • REPEATED 14-DAY COURSES (IF NEEDED) • • • OTHER INFORMATION • • • INACTIVE INGREDIENTS carnauba wax, FD&C blue #1/brilliant blue FCF aluminum lake, hypromellose, hypromellose acetate succinate, lactose monohydrate, menthol, monoethanolamine, sodium lauryl sulfate, sodium starch glycolate, sodium stear Read the complete document