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西药 · 美国药品标签原文

埃索美拉唑 · Esomeprazole

ESOMEPRAZOLE MAGNESIUM

Esomeprazole · YYBA CORP。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 ESOMEPRAZOLE MAGNESIUM METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYSORBATE 80 POTASSIUM HYDROXIDE PROPYLENE GLYCOL FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE 2208 (100 MPA.S) MAGNESIUM STEARATE SHELLAC TALC TITANIUM DIOXIDE TRIETHYL CITRATE STARCH, CORN SUCROSE FD&C BLUE NO. 1 FD&C RED NO. 3 GLYCERYL MONOSTEARATE ESOMEPRAZOLE MAGNESIUM ESOMEPRAZOLE RG;50

spl unclassified section

Drug Facts

活性成分 / Active ingredient

Active ingredient (in each capsule) *Esomeprazole 20 mg (Each delayed-release capsule contains 22.3 mg esomeprazole magnesium trihydrate)

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 esomeprazole Esomeprazole may cause severe skin reactions. Symptoms 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 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

warnings table

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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 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 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 swallow whole. Do not crush or chew capsules. 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.

其他安全资料 / Other safety information

Other information read the directions and warnings before use. Store at 20°C to 25°C (68°F to 77°F). [See USP controlled room temperature.] keep the carton. It contains important information.

辅料 / Inactive ingredients

Inactive Ingredients FD & C blue no 1, FD & C red no 3, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer dispersion, mono and di glycerides, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate.

questions

Questions? Call toll-free weekdays 9 AM to 6 PM EST at 866-933-6337. TAMPER-EVIDENT FEATURES: Do not use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" or blue band around center of each capsule is broken or missing. 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: Wellspring Airmont, NY 10952, U.S.A. R0922

package label principal display panel

PRINCIPAL DISPLAY PANEL - 42 Capsule Bottle Carton welmate ® NDC 73581-013-42 HEARTBURN RELIEF ACID REDUCER Esomeprazole Magnesium USP, 20 mg* ✓Treats Frequent Heartburn ✓May Take 1 to 4 Days for Full Effect 24 HOUR 42 DELAYED-RELEASE CAPSULES 3 X 14 Count Bottles Inside Three 14-day courses of treatment RECOMMENDED BY HEALTHCARE PROFESSIONALS welmate-Esomeprazole-42s

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20251119
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