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西药 · 美国药品标签原文

奥美拉唑 · 奥美拉唑 · Omeprazole

OMEPRAZOLE

Omeprazole · AMERISOURCEBERGEN DRUG CORPORATION。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

Omeprazole Omeprazole OMEPRAZOLE OMEPRAZOLE AMMONIA CARNAUBA WAX HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S) HYPROMELLOSES FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MONOETHANOLAMINE BUTYL ALCOHOL Polyethylene Glycol 3350 POLYVINYL ALCOHOL POVIDONE PROPYLENE GLYCOL FERRIC OXIDE RED SODIUM STEARATE SODIUM STARCH GLYCOLATE TYPE A POTATO SHELLAC SODIUM LAURYL SULFATE SODIUM STEARYL FUMARATE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW brownish pink O20 Label carton

活性成分 / Active ingredient

Active ingredient(s) Omeprazole USP, 20 mg

用途 / Purpose

Purpose Acid reducer

适应证 / Indications and usage

Use(s) 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 lightheadednes 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 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 lightheadednes frequent chest pain These may be signs of a serious condition. See your 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 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 or crush 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.

spl unclassified section

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

辅料 / Inactive ingredients

Inactive ingredients ammonia solution, ammonium hydroxide, carnauba wax, hypromellose acetate succinate, hypromellose, iron oxide black, lactose monohydrate, monoethanolamine, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, red iron oxide, sodium stearate, sodium starch glycolate, shellac glaze, sodium lauryl sulphate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate, yellow iron oxide

questions

Questions or comments? call 1-888-375-3784 Distributed By AmerisourceBergen 1 West First Avenue Conshohocken PA 19428 Made in India

package label principal display panel

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION Carton Label - 14 count

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20260417
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