NDC 0113-0058 Good Sense Omeprazole And Sodium Bicarbonate

Omeprazole, Sodium Bicarbonate

NDC Product Code 0113-0058

NDC CODE: 0113-0058

Proprietary Name: Good Sense Omeprazole And Sodium Bicarbonate What 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, Sodium Bicarbonate What 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

Shape: OVAL (C48345)
23 MM
Score: 1

NDC Code Structure

  • 0113 - L. Perrigo Company
    • 0113-0058 - Good Sense Omeprazole And Sodium Bicarbonate

NDC 0113-0058-03

Package Description: 3 BOTTLE in 1 CARTON > 14 CAPSULE, GELATIN COATED in 1 BOTTLE

NDC Product Information

Good Sense Omeprazole And Sodium Bicarbonate with NDC 0113-0058 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Omeprazole And Sodium Bicarbonate is omeprazole, sodium bicarbonate. The product's dosage form is capsule, gelatin coated and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 616539.

Dosage Form: Capsule, Gelatin Coated - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin; through a banding process, the capsule is coated with additional layers of gelatin so as to form a complete seal.

Product Type: Human Otc Drug 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.

Good Sense Omeprazole And Sodium Bicarbonate Active Ingredient(s)

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

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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • GELATIN (UNII: 2G86QN327L)

Administration Route(s)

What 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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Cytochrome P450 2C19 Inhibitors - [MoA] (Mechanism of Action)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitor - [EPC] (Established Pharmacologic Class)
  • Proton Pump Inhibitors - [MoA] (Mechanism of Action)

Product Labeler Information

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

Labeler Name: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: ANDA201361 What 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. What 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: 06-19-2017 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: 12-31-2022 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: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Good Sense Omeprazole And Sodium Bicarbonate Product Label Images

Good Sense Omeprazole And Sodium Bicarbonate 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 Ingredients (In Each Capsule)

Omeprazole 20 mgSodium Bicarbonate 1100 mg


Acid reducerAllows absorption of this omeprazole product


  • •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.


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 •bloody or black stoolsThese 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. •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 •frequent wheezing, particularly with heartburn •unexplained weight loss •nausea or vomiting •stomach pain •a sodium-restricted diet

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) •any other prescription drugs. Sodium bicarbonate may interact with certain prescription 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

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).


  • •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, although some people get complete relief of symptoms within 24 hours14-Day Course of Treatment •swallow 1 capsule with a glass of water at least 1 hour before eating in the morning •take every day for 14 days •do not take more than 1 capsule a day •do not chew or crush the capsule •do not open capsule and sprinkle on food •do not use for more than 14 days unless directed by your doctorRepeated 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

  • •each capsule contains: sodium 303 mg •read the directions, warnings and accompanying label information before use •store at 20-25oC (68-77oF) •tamper-evident: do not use if the band around the capsule is missing or broken. Do not use if printed seal under cap is broken or missing. •keep product out of high heat and humidity •protect product from moisture

Inactive Ingredients

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

* Please review the disclaimer below.