Drug Facts
Composition & Profile
Identifiers & Packaging
Package/Label Principal Display Panel NDC 57483-740-42 Compare To the active ingredient of Prilosec OTC ® Treats FREQUENT Heartburn! OmepraCareDR ™ Omeprazole Delayed-release Capsules 20 mg* Acid Reducer Mini Cap 40% Smaller Capsule 24HR 42 CAPSULES Three 14-DAY courses of treatment May take 1 to 4 days for full effect spl-innovus-carton
- Package/Label Principal Display Panel NDC 57483-740-42 Compare To the active ingredient of Prilosec OTC ® Treats FREQUENT Heartburn! OmepraCareDR ™ Omeprazole Delayed-release Capsules 20 mg* Acid Reducer Mini Cap 40% Smaller Capsule 24HR 42 CAPSULES Three 14-DAY courses of treatment May take 1 to 4 days for full effect spl-innovus-carton
Overview
Use ▪ 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
Indications & Usage
Use ▪ 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
Dosage & Administration
Directions ▪ for adults 18 years of age and older ■ this product is to be used once a day (every 24 hours), every day for 14 days ■ it may take 1 to 4 days for full effect; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment ■ swallow 1 capsule with a glass of water before eating in the morning ■ take every day for 14 days ■ do not take more than 1 capsule a day ■ do not use for more than 14 days unless directed by your doctor ■ swallow whole. Do not chew or crush capsules. Repeated 14-Day Courses (if needed) ■ you may repeat a 14-day course every 4 months ■ do not take for more than 14 days or more often than every 4 months unless directed by a doctor ▪ children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition. Other information ▪ read the directions and warnings before use ■ keep the carton. It contains important information. ■ Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture
Warnings & Precautions
Warnings Allergy alert: Do not use if you are allergic to omeprazole. Do not use if you have: ■ 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 These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have: ■ 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 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: ■ 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 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).
Purpose
Purpose Acid reducer
Keep Out of Reach of Children
Keep Out of Reach of Children
Questions
Questions Call toll-free Monday to Friday 8:30 am to 5 pm EST at 1-800-818-4555 .
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