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西药 · 美国药品标签原文

奥美拉唑 · 奥美拉唑 · careone omeprazole

OMEPRAZOLE

careone omeprazole · Retail Business Services, LLC。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

careone omeprazole omeprazole OMEPRAZOLE OMEPRAZOLE CARNAUBA WAX FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED HYPROMELLOSE ACETATE SUCCINATE, UNSPECIFIED LACTOSE MONOHYDRATE MENTHOL, UNSPECIFIED FORM MONOETHANOLAMINE SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A SODIUM STEARATE SODIUM STEARYL FUMARATE SUCRALOSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 20 COOL

活性成分 / Active ingredient

Active ingredient (in each tablet) Omeprazole 20 mg

用途 / Purpose

Purpose Acid reducer

适应证 / Indications and 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

警告 / Warnings

Warnings Allergy alert: • do not use if you are allergic to omeprazole. • omeprazole may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If an allergic reaction occurs, stop use and seek medical help right away. 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 you 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).

禁用事项 / Do not use

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 you doctor.

咨询医生 / Ask a 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

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

停用事项 / Stop use

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

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

儿童安全 / Keep out of reach of children

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).

用法用量原文 / Dosage and 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 tablet with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 tablet a day • do not use for more than 14 days unless directed by your doctor • swallow whole. Do not chew, crush, or suck tablets. 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.

储存 / Storage and handling

Other information • read the directions and warnings before use • keep the carton. It contains important information. • store at 20-25°C (68-77°F) and protect from moisture

辅料 / Inactive ingredients

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 stearate, sodium stearyl fumarate, sucralose, talc, titanium dioxide, triacetin, triethyl citrate

questions

Questions or comments? 1-800-719-9260

package label principal display panel

Package/Label Principal Display Panel CAREone™ Compare to Prilosec OTC ® OMEPRAZOLE Delayed Release Tablets 20 mg Acid Reducer Treats Frequent Heartburn! OUR PHARMACISTS RECOMMEND 42 TABLETS Three 14-day courses of treatment May take 1 to 4 days for full effect 24 HR Actual Size Cool Mint Coated Tablet SWALLOW – DO NOT CHEW 47k-of-omeprazole-1.jpg 47k-of-omeprazole-2.jpg

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20250417
获取时间
2026-10-08
许可
openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.
核对原始来源