NDC 63868-170 Quality Choice Omeprazole

NDC Product Code 63868-170

NDC 63868-170-42

Package Description: 3 BLISTER PACK in 1 CARTON > 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Quality Choice Omeprazole with NDC 63868-170 is a product labeled by Chain Drug Marketing Association. The generic name of Quality Choice Omeprazole is . The product's dosage form is and is administered via form.

Labeler Name: Chain Drug Marketing Association

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S) (UNII: 36BGF0E889)
  • LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
  • MONOETHANOLAMINE (UNII: 5KV86114PT)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • SODIUM STEARATE (UNII: QU7E2XA9TG)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Chain Drug Marketing Association
Labeler Code: 63868
Start Marketing Date: 03-01-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Omeprazole

Omeprazole is pronounced as (oh me' pray zol)

Why is omeprazole medication prescribed?
Prescription omeprazole is used alone or with other medications to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stoma...
[Read More]

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Quality Choice Omeprazole Product Label Images

Quality Choice Omeprazole Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Tablet)

Omeprazole delayed-release tablet, 20 mg

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 omeprazoleDo not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.Ask a doctor before use if you havehad heartburn over 3 months. This may be a sign of a more serious condition.heartburn with lightheadedness, sweating or dizzinesschest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadednessfrequent chest painfrequent wheezing, particularly with heartburnunexplained weight lossnausea or vomitingstomach painAsk a doctor or pharmacist before use if you are takingwarfarin, clopidogrel or cilostazol (blood-thinning medicines)prescription antifungal or anti-yeast medicinesdiazepam (anxiety medicine)digoxin (heart medicine)tacrolimus (immune system medicine)prescription antiretrovirals (medicines for HIV infection)Stop use and ask a doctor ifyour heartburn continues or worsensyou need to take this product for more than 14 daysyou need to take more than 1 course of treatment every 4 monthsyou get diarrheaIf pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

Directions

  • Adults 18 years of age and olderthis product is to be used once a day (every 24 hours), every day for 14 daysit may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatmentswallow 1 tablet with a glass of water before eating in the morningtake every day for 14 daysdo not take more than 1 tablet a daydo not use for more than 14 days unless directed by your doctorswallow whole. Do not chew or crush tabletsRepeated 14-Day Courses (if needed)you may repeat a 14-day course every 4 monthsdo not take for more than 14 days or more often than every 4 months unless directed by a doctorchildren 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 usekeep the carton. It contains important information.store at 20-25°C (68-77°F) keep product out of high heat and humidityprotect product 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

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