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西药 · 美国药品标签原文

埃索美拉唑 · Esomeprazole Magnesium

ESOMEPRAZOLE MAGNESIUM

Esomeprazole Magnesium · Aurohealth 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

Esomeprazole Magnesium Esomeprazole Magnesium ESOMEPRAZOLE MAGNESIUM DIHYDRATE ESOMEPRAZOLE SILICON DIOXIDE CROSPOVIDONE (120 .MU.M) HYDROXYPROPYL CELLULOSE (20000 WAMW) HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 130000 MW) MAGNESIUM CARBONATE MAGNESIUM OXIDE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A POLYSORBATE 80 SODIUM LAURYL SULFATE MICROCRYSTALLINE CELLULOSE 301 MICROCRYSTALLINE CELLULOSE 302 GLYCERYL MONO AND DIPALMITOSTEARATE POLYETHYLENE GLYCOL 6000 FERRIC OXIDE RED SODIUM STEARYL FUMARATE DEXTROSE, UNSPECIFIED FORM STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW Light pink Oblong, Biconvex K;12

活性成分 / Active ingredient

Drug Facts Active ingredient (in each tablet) *Esomeprazole 20 mg (Each film-coated delayed-release tablet corresponds to 21.75 mg esomeprazole magnesium dihydrate USP)

用途 / Purpose

Purpose Acid reducer

适应证 / Indications and usage

Uses 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 esomeprazole. ■ Esomeprazole 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.

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 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 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.

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 adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 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 swallow whole. Do not crush or chew tablets. do not use for more than 14 days unless directed by your doctor 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 before use. 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° to 25°C (68° to 77°F)

辅料 / Inactive ingredients

Inactive ingredients colloidal silicon dioxide, crospovidone, hydroxy propyl cellulose, hypromellose, low substituted hydroxy propyl cellulose, magnesium carbonate, magnesium oxide, methacrylic acid and ethyl acrylate copolymer dispersion (which contains copolymer based on ethyl acrylate and methacrylic acid, polysorbate 80 and sodium lauryl sulfate), microcrystalline cellulose, mono and di-glycerides, polyethylene glycol, polysorbate 80, red iron oxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide. Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Tips for Managing Heartburn Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables. Eat slowly and do not eat big meals. Do not eat late at night or just before bedtime. Do not lie flat or bend over soon after eating. Raise the head of your bed. Wear loose-fitting clothing around your stomach. If you are overweight, lose weight. If you smoke, quit smoking. Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India

package label principal display panel

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets) AUROHEALTH NDC 58602-840-05 Esomeprazole Magnesium Delayed-Release Tablets 20 mg* Acid Reducer 24 HR May take 1 to 4 days for full effect Treats Frequent Heartburn 14 Tablets Tablets One 14-day course of treatment PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (42 Tablets) #Compare to Nexium ® 24 HR Active ingredient AUROHEALTH NDC 58602-840-62 See new warning information Esomeprazole Magnesium Delayed-Release Tablets 20 mg* Acid Reducer 24 HR Treats Frequent Heartburn May take 1 to 4 days for full effect Actual Size Tablets 42 Tablets (3 bottles of 14 each) Three 14-day courses of treatment PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablets)

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20260212
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