NDC 55319-191 Family Wellness Omeprazole

Omeprazole

NDC Product Code 55319-191

NDC Code: 55319-191

Proprietary Name: Family Wellness Omeprazole Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Omeprazole Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Product Characteristics
Color(s):
RED (C48326 - REDDISH)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
20
Score: 1
Flavor(s):
STRAWBERRY (C73417)

Code Structure
  • 55319 - Family Dollar Services Inc
    • 55319-191 - Family Wellness Omeprazole

NDC 55319-191-74

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

NDC Product Information

Family Wellness Omeprazole with NDC 55319-191 is a a human over the counter drug product labeled by Family Dollar Services Inc. The generic name of Family Wellness Omeprazole is omeprazole. The product's dosage form is tablet, orally disintegrating, delayed release and is administered via oral form.

Labeler Name: Family Dollar Services Inc

Dosage Form: Tablet, Orally Disintegrating, Delayed Release - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue, but which releases a drug (or drugs) at a time other than promptly after administration.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Family Wellness Omeprazole Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OMEPRAZOLE 20 mg/1

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MANNITOL (UNII: 3OWL53L36A)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM STEARATE (UNII: QU7E2XA9TG)
  • SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Family Dollar Services Inc
Labeler Code: 55319
FDA Application Number: NDA209400 Additional informationCallout TooltipWhat is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-26-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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: N Additional informationCallout TooltipWhat 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’.

* Please review the disclaimer below.

Family Wellness Omeprazole Product Label Images

Family Wellness 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 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 omeprazole

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 or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness •frequent chest painThese 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: •warfarin, clopidogrel or cilostazol (blood-thinning medicines) •prescription antifungal or anti-yeast medicines •diazepam (anxiety medicine) •digoxin (heart medicine) •tacrolimus or mycophenolate mofetil (immune system medicines) •prescription antiretrovirals (medicines for HIV infection) •methotrexate (arthritis medicine)

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 hours14-Day Course of Treatment •take 1 tablet before eating in the morning •do not crush or chew tablets •place the tablet on tongue; tablet disintegrates, with or without water. The tablets can also be swallowed whole with water. •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 •do not take this medicine with alcoholRepeated 14-Day Course (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 before use. 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); keep product out of high heat and moisture

Inactive Ingredients

Amino methacrylate copolymer, ascorbic acid, cetyl alcohol, colloidal silicon dioxide, crospovidone, ferric oxide, flavor, hypromellose, hypromellose phthalate, maize maltodextrin, mannitol, microcrystalline cellulose, propylene glycol, silicon dioxide, sodium stearate, sodium stearyl fumarate, sorbitol, sucralose, sugar spheres, talc, titanium dioxide, triethyl citrate

* Please review the disclaimer below.

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