NDC 46122-686 Omeprazole
Capsule, Delayed Release Oral
What is NDC 46122-686?
The NDC code 46122-686 is assigned by the FDA to the product Omeprazole which is a human over the counter drug product labeled by Amerisource Bergen. The product's dosage form is capsule, delayed release and is administered via oral form. The product is distributed in a single package with assigned NDC code 46122-686-03 2 bottle in 1 blister pack / 14 capsule, delayed release in 1 bottle (46122-686-74). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Omeprazole?
Omeprazole is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Omeprazole belongs to a class of drugs known as proton pump inhibitors (PPIs). If you are self-treating with this medication, over-the-counter omeprazole products are used to treat frequent heartburn (occurring 2 or more days a week). Since it may take 1 to 4 days to have full effect, these products do not relieve heartburn right away. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar brand names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
|Color(s)||PINK (C48328) |
|Shape||CAPSULE (C48336) |
|Size(s)||18 MM |
NDC Code 46122-686-03
Package Description: 2 BOTTLE in 1 BLISTER PACK / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46122-686-74)
Price per Unit: $0.36791 per EA
What are Omeprazole Active Ingredients?
- OMEPRAZOLE MAGNESIUM 20.6 mg/1 - A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.
Omeprazole Active Ingredients UNII Codes
- OMEPRAZOLE MAGNESIUM (UNII: 426QFE7XLK)
- OMEPRAZOLE (UNII: KG60484QX9) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 198051 - omeprazole 20 MG Delayed Release Oral Capsule
- RxCUI: 198051 - omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral Capsule
Omeprazole Inactive Ingredients UNII Codes
- FERROSOFERRIC OXIDE (UNII: XM0M87F357)
- GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
- HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
- MAGNESIUM CARBONATE (UNII: 0E53J927NA)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)
- POLYSORBATE 80 (UNII: 6OZP39ZG8H)
- POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- SHELLAC (UNII: 46N107B71O)
- SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
- STARCH, CORN (UNII: O8232NY3SJ)
- SUCROSE (UNII: C151H8M554)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
* Please review the disclaimer below.
Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with GERD. Prescription omeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome in adults. Prescription omeprazole is also used to treat ulcers (sores in the lining of the stomach or intestine) and it is also used with other medications to treat and prevent the return of ulcers caused by a certain type of bacteria (H. pylori) in adults. Nonprescription (over-the-counter) omeprazole is used to treat frequent heartburn (heartburn that occurs at least 2 or more days a week) in adults. Omeprazole is in a class of medications called proton-pump inhibitors. It works by decreasing the amount of acid made in the stomach.
* Please review the disclaimer below.
Omeprazole Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Active Ingredient (In Each Capsule)
*Omeprazole delayed-release capsule 20 mg (equivalent to 20.6 mg omeprazole magnesium, USP)
•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
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 pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness •frequent chest pain •had heartburn over 3 months. •frequent wheezing, particularly with heartburn •unexplained weight loss •nausea or vomiting •stomach pain •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
These may be signs of a serious condition. See your doctor.
Ask a doctor before use if you have:
This may be a sign of a more serious condition.
Ask a doctor or pharmacist before use if you are taking a prescription drug.
Acid reducers may interact with certain prescription drugs.
Stop use and ask a doctor if:
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; some people get complete relief of symptoms within 24 hours •swallow 1 capsule with a glass of water before eating in the morning •take every day for 14 days •do not take more than 1 capsule a day •do not use for more than 14 days unless directed by your doctor •swallow whole. Do not chew or crush capsules. •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.
14-Day Course of Treatment
Repeated 14-Day Courses (if needed)
•read the directions and warnings before use •keep the carton. It contains important information. •Store at 20-25°C (68-77°F). [See USP controlled room temperature]. Protect from moisture
FD&C blue #1, FD&C red #40, ferrosoferric oxide, gelatin, hydroxypropyl cellulose, hypromellose, magnesium carbonate, magnesium stearate, methacrylic acid copolymer, mono and di glycerides, polyethylene glycol 6000, polysorbate 80, potassium hydroxide, propylene glycol, shellac, sodium stearyl fumarate, sugar spheres (starch and sucrose), talc, titanium dioxide and triethyl citrate
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Package/Label Principal Display Panel
†Compare To Prilosec OTC®
2x14 COUNT BOTTLE INSIDE
Treats FREQUENT Heartburn!
20 mg* / Acid Reducer
Two 14-day courses of treatment
May take 1 to 4 days for full effect
* Please review the disclaimer below.