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西药 · 美国药品标签原文

奥美拉唑 · Omeprazole Magnesium

OMEPRAZOLE MAGNESIUM

Omeprazole Magnesium · Dr. Reddy's Laboratories Limited。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 Magnesium Omeprazole Magnesium OMEPRAZOLE MAGNESIUM omeprazole FERROSOFERRIC OXIDE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CARRAGEENAN GLYCERYL MONOSTEARATE HYPROMELLOSES HYPROMELLOSE 2208 (3 MPA.S) MAGNESIUM OXIDE MAGNESIUM STEARATE METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A CELLULOSE, MICROCRYSTALLINE POTASSIUM CHLORIDE POTASSIUM HYDROXIDE PROPYLENE GLYCOL FERRIC OXIDE RED SHELLAC SILICON DIOXIDE RAW SUGAR TALC TITANIUM DIOXIDE TRIETHYL CITRATE OMP20 Drug Facts Bottle Carton

活性成分 / Active ingredient

Active ingredient (in each capsule) *Omeprazole delayed-release capsules 20 mg (equivalent to 20.6 mg omeprazole magnesium)

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 c hest 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 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 c hest 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 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 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.

spl unclassified section

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 Tips for Managing Heartburn Do not lie flat or bend over after eating Do not wear tight-fitting clothing around the stomach Do not eat before bedtime Raise the head of your bed Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol and certain fruits and vegetables Eat slowly and avoid big meals If overweight, lose weight Quit smoking Revised: 10/2022

辅料 / Inactive ingredients

Inactive ingredients black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, triethyl citrate

questions

Questions call 1-888-375-3784

package label principal display panel

Bottle Label Dr.Reddy's NDC 55111-397-52 Treats Frequent Heartburn! 24 HR Omeprazole Delayed Release- Capsules 20 mg* ACID REDUCER 14 Capsules(Safety Sealed) One 14-Day Course of Treatment May take 1 to 4 days for full effect Carton Label Dr.Reddy's NDC 55111-397-52 Compare to the active ingredient in Prilosec OTC ® ** Treats Frequent Heartburn! 24 HR Omeprazole Delayed Release- Capsules 20 mg* ACID REDUCER 14 Capsules(Safety Sealed) One 14-Day Course of Treatment May take 1 to 4 days for full effect

来源、版本与许可

资料类型
美国药品标签原文
版本
22 / 20250528
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