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| Product NDC Code | 0536-1322 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Acid reducer |
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| Type | Brand | ||||||||
| Pharm Class | Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||||||
| Dosage Form | TABLET, DELAYED RELEASE | ||||||||
| RxCUI drug identifier | 402014 | ||||||||
| Application Number | ANDA206877 | ||||||||
| Labeler Name | Rugby Laboratories | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium USP)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 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. 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients crospovidone, glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, microcrystalline cellulose, polyethylene glycol, polysorbate 80, red iron oxide, silicified microcrystalline cellulose, sodium hydroxide, sodium stearyl fumarate, sugar spheres [which contains liquid glucose, starch (maize) and sucrose], talc, titanium dioxide, triethyl citrate and yellow iron oxide.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Acid reducer
Spl product data elements
Usually a list of ingredients in a drug product.Acid Reducer Omeprazole OMEPRAZOLE MAGNESIUM OMEPRAZOLE CROSPOVIDONE (35 .MU.M) GLYCERYL MONOSTEARATE HYDROXYPROPYL CELLULOSE (90000 WAMW) HYPROMELLOSE 2910 (5 MPA.S) MAGNESIUM STEARATE METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 4000 POLYSORBATE 80 FERRIC OXIDE RED SILICON DIOXIDE SODIUM HYDROXIDE SODIUM STEARYL FUMARATE DEXTROSE, UNSPECIFIED FORM STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE (45000 WAMW) HYPROMELLOSE 2910 (6 MPA.S) Oblong Z;69
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle) Rugby ® NDC 0536-1322-88 Omeprazole Delayed-Release Tablets 20 mg Acid Reducer 24 Hour Treats Frequent Heartburn 14 Tablets One 14-day course of treatment May take 1 to 4 days for full effect PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (14 Tablet Bottle)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label Rugby ® NDC 0536-1322-88 Compare to the active ingredient in Prilsec OTC ® * Omeprazole Delayed-Release Tablets 20 mg Acid Reducer Actual Size 24 Hour Treats Frequent Heartburn 14 Tablets One 14-day course of treatment May take 1 to 4 days for full effect PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg Container Carton Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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
Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-800-645-2158 Distributed by: RUGBY ® LABORATORIES 17177N Laurel Park Drive, Suite 233 Livonia, MI 48152 Made in India Code: TS/DRUGS/22/2009
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information read the directions and warnings before use keep the carton. It contains important information. store at 20º to 25ºC (68º to 77º F) and protect from moisture
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Allergy alert: Do not use if you are allergic to omeprazole
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API