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NDC 55111-0397-52 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 Dr. Reddy's Laboratories Limited. 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: 55111-0397-52
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Omeprazole

Product Information

NDC	55111-0397
Product ID	55111-397_41f88be5-fb44-24af-30db-543aacb1a040
Associated GPIs	49270060106520
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
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	Dr. Reddy's Laboratories Limited
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 55111-0397-52 (55111039752)

Pricing Information
NDC Package Code	55111-397-52
Billing NDC	55111039752
Package	1 BOTTLE in 1 CARTON (55111-397-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
Marketing Start Date	2010-03-01
NDC Exclude Flag	N
Price Per Unit	0.38684
Pricing Unit	EA
Effective Date	2024-02-21
NDC Description	OMEPRAZOLE MAG DR 20.6 MG CAP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 0e8fde83-a55c-edaf-3c66-e1fc77d0bc11 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 a prescription drug.

Acid reducers may interact with certain prescription drugs.

Stop use and ask 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 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 sulfate, 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

Revised: 0419

Bottle Label

Dr.Reddy's

NDC 55111-397-52

Treats Frequent Heartburn! 24 HR

Omeprazole

Delayed Release- Capsules

20 mg*

ACID REDUCER

14 Capsules(Safety Sealed)

One 14-Day Course of Treatment

May take 1 to 4 days for full effect

Carton Label