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NDC 11673-0397-33 Omeprazole Magnesium 20 mg/1 Details

Omeprazole Magnesium 20 mg/1

Omeprazole Magnesium is a ORAL CAPSULE, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Target Corporation. The primary component is OMEPRAZOLE MAGNESIUM.

MedlinePlus Drug Summary

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.

Related Packages: 11673-0397-33
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Omeprazole

Product Information

NDC	11673-0397
Product ID	11673-397_86d2fc65-c13e-6d7f-3e7e-dd15a610b8a7
Associated GPIs
GCN Sequence Number	066403
GCN Sequence Number Description	omeprazole magnesium CAPSULE DR 20 MG ORAL
HIC3	D4J
HIC3 Description	PROTON-PUMP INHIBITORS
GCN	28664
HICL Sequence Number	011115
HICL Sequence Number Description	OMEPRAZOLE MAGNESIUM
Brand/Generic	Generic
Proprietary Name	Omeprazole Magnesium
Proprietary Name Suffix	n/a
Non-Proprietary Name	Omeprazole Magnesium 20.6mg Capsules
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE, DELAYED RELEASE
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/1
Substance Name	OMEPRAZOLE MAGNESIUM
Labeler Name	Target Corporation
Pharmaceutical Class	Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA078878
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11673-0397-33 (11673039733)

Pricing Information	N/A
NDC Package Code	11673-397-33
Billing NDC	11673039733
Package	3 BOTTLE in 1 CARTON (11673-397-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date	2016-03-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4a66a130-cdc5-4717-8902-511fa7603154 Details

Active ingredient (in each capsule)

*Omeprazole delayed-release capsules 20 mg

(equivalent to 20.6 mg omeprazole magnesium)

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 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.

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

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.

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 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.
  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.

Other information

read the directions and warnings before use
keep the carton. It contains important information.
store at 20-25°C (68-77°F) and protect from moisture

Inactive ingredients

black iron oxide, dibasic calcium phosphate, gelatin, glyceryl monostearate, hypromellose 3 cps, magnesium oxide, magnesium stearate, methacrylic acid copolymer dispersion, methacrylic acid copolymer Type B, microcrystalline cellulose, polysorbate 80, potassium hydroxide, propylene glycol, red iron oxide, shellac, silicon dioxide, sodium lauryl sulphate, sugar spheres, talc, titanium dioxide, triethyl citrate

Questions?

call 1-888-375-3784

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

Omeprazole Delayed-Release Capsules, 20 mg*, 14-count - Carton Label

NDC 11673-397-52

omeprazole

delayed-release capsules

20 mg*

acid reducer

Compare to the active

ingredient in Prilosec OTC®**

treats frequent heartburn

occuring two or more

days a week!

14 CAPSULES (SAFETY SEALED)

ONE 14-DAY COURSE OF TREATMENT

Omeprazole Delayed-Release Capsules, 20 mg*, 14-count - Bottle Label