Active Ingredient (In Each Tablet)
Omeprazole 20 mg
Rugby Omeprazole Tablet, Delayed Release
FDA Label NDC 0536-1448
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Omeprazole (NDC 0536-1448). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, use, warnings, do not use if you have:, ask a doctor before use if you have:, stop use and ask a doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Acid reducer
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
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 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
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.
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).
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
- 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.
- 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 20-25°C (68-77°F) and protect from moisture
Inactive Ingredients
carnauba wax, ferric oxide red, ferric oxide yellow, hypromellose, hypromellose acetate succinate, lactose monohydrate, monoethanolamine, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, sodium stearate, sodium stearyl fumarate, talc, titanium dioxide, triethyl citrate
Questions Or Comments?
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Rugby®
compare to Prilosec OTC®
omeprazole delayed release tablets
20 mg
acid reducer
24 HR
treats frequent heartburn!
one 14-day course of treatment
may take 1 to 4 days for full effect
14 tablets
actual size
Rugby-omeprazole-carton-image.jpg (Rugby Omeprazole Carton Image)
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