OMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS
Omeprazole by
Drug Labeling and Warnings
Omeprazole by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
OMEPRAZOLE- omeprazole magnesium tablet, delayed release
P & L Development, LLC
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OMEPRAZOLE MAGNESIUM DELAYED-RELEASE TABLETS
ACTIVE INGREDIENT
(in each tablet)
Omeprazole delayed-release tablet 20 mg
(equivalent to 20.6 mg omeprazole magnesium)
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
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
Ask a doctor or pharmacist before use if you are
taking a prescription drug.
Acid reducers may interact with certain 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
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
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 everyday 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.
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
Inactive ingredients
acetyl tributyl citrate, colloidal silicon dioxide, corn starch, croscarmellose sodium, hydroxypropyl cellulose, hypromellose 2910, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 3350, polyethylene glycol 8000, polyvinyl alcohol, red iron oxide, sucrose, talc, titanium dioxide, triethyl citrate
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
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omeprazole magnesium tablet, delayed release |
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| Labeler - P & L Development, LLC (800014821) |
Revised: 4/2023
Document Id: 374eac2d-56c9-4973-acb1-710620384e70
Set id: c9d30986-304a-408a-a48c-eee1ed0bf301
Version: 16
Effective Time: 20230420