Omeprazole (Omeprazole)

Trade Name : Omeprazole

RPK Pharmaceuticals, Inc.

CAPSULE, DELAYED RELEASE

Strength 20 mg/1

OMEPRAZOLE Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Omeprazole (Omeprazole) which is also known as Omeprazole and Manufactured by RPK Pharmaceuticals, Inc.. It is available in strength of 20 mg/1 per ml. Read more

Omeprazole (Omeprazole) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

Contraindications 02/2016
Warnings and Precautions, Atrophic Gastritis removed 10/2016
Warnings and Precautions, Cutaneous and Systemic Lupus 10/2016
Erythematosus (n

Omeprazole is a proton pump inhibitor (PPI) indicated for the:
u2022 Treatment of active duodenal ulcer in adults n
u2022 Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults n
u2022 Treatment of active benign gastric ulcer in adults n
u2022 Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older n
u2022 Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older n
u2022 Pathologic hypersecretory conditions in adults n

* if ulcer present, continue omeprazole delayed-release capsules 20 mg once daily for an additional 18 days.
** if ulcer present, continue omeprazole delayed-release capsules 20 mg once daily for an additional 14 days.
*** an additional 4 weeks of treatment may be given if no response; if recurrence additional 4 to 8 week courses may be considered.
**** studied for 12 months. Reduce the dosage to 10 mg once daily for patients with hepatic impairment (Child-Pugh Class A, B, or C) and Asian patients (, )

Omeprazole delayed-release capsules, USP 10 mg are off-white to pale yellow, elliptical to spherical pellets filled in size u20183u2019 hard gelatin capsules with opaque lavender coloured cap and opaque yellow coloured body, imprinted on cap u2018OMEPRAZOLEu2019u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a010 mg
u00a0and on body u2018R157u2019 with black ink.
Omeprazole delayed-release capsules, USP 20 mg are off-white to pale yellow, elliptical to spherical pellets filled in size u20182u2019 hard gelatin capsules with opaque lavender coloured cap and opaque iron grey coloured body, imprinted on cap u2018OMEPRAZOLEu2019
20 mgu00a0u00a0
and on body u2018R158u2019 withu00a0blacku00a0ink.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size u2018Ou2019 hard gelatin capsules with opaque yellow coloured cap and opaque lavender coloured body, imprinted on cap u2018OMEPRAZOLEu2019
40 mg
and on body u2018R159u2019 with black ink.
u00a0u00a0

Omeprazole delayed-release capsules, 10 mg, 20 mg and 40 mg n

u2022 Omeprazole is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria [see Warnings and Precautions , Adverse Reactions ].
u2022 Proton pump inhibitors (PPIs), including omeprazole, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactionsn ].
u2022 For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole, refer to the CONTRAINDICATIONS section of their package inserts.
u2022 Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation. n
u2022 Patients receiving rilpivirine-containing products. (, )
u2022 Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with omeprazole. n

No data

Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. n
Acute Interstitial Nephritis: Observed in patients taking PPIs. n
Clostridium difficile-Associated Diarrhea: PPI therapy may be associated with increased risk. n
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.n
Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue omeprazole and refer to specialist for evaluation n
Interaction with Clopidogrel: Avoid concomitant use of omeprazole. (, )
Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ()
Hypomagnesemia: Reported rarely with prolonged treatment with PPIs. n
Interaction with St. Johnu2019s Wort or Rifampin: Avoid concomitant use of omeprazole. (, )
Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Increased Chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors; temporarily stop omeprazole at least 14 days before assessing CgA levels. (, )
Interaction with Methotrexate: Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of omeprazole (, ).

The following serious adverse reactions are described below and elsewhere in labeling:
u2022 Acute Interstitial Nephritis [see ]
u2022 -Associated Diarrhea [see ]
u2022 Bone Fracture [see ]
u2022 Cutaneous and Systemic Lupus Erythematosus [see ]
u2022 Cyanocobalamin (Vitamin B-12) Deficiency [see ]
u2022 Hypomagnesemia [see ]
Adults: Most common adverse reactions in adults (incidence u22652%) are
u2022 Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence n
Pediatric patients (2 to 16 years of age):
u2022 Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. n
To report SUSPECTED ADVERSE REACTIONS, contactu00a0Dr. Reddyu2019s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. u00a0
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. u00a0 n
Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics
Table 4: Clinically Relevant Interactions Affecting Omeprazole When Co-Administered with Other Drugs
See full prescribing information for a list of clinically important drug interactions. (7)

Consider dose reduction, particularly for maintenance of healing erosive esophagitis n

Pregnancy: Based on animal data may cause fetal harm n
Patients with hepatic impairment: n

Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience [see ]. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. u00a0
If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is CHNOS, with a molecular weight of 345.42. The structural formula is:
Omeprazole is a white to off-white powder. Melts between 150u00b0C and 160u00b0C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water.
Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide.
Omeprazole delayed-release capsules meets USP .u00a0u00a0u00a0

No data

In two 24-month carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44 and 140.8 mg/kg/day (about 0.4 to 34 times a human dose of 40 mg/day, as expressed on a body surface area basis) produced gastric ECL cell carcinoids in a dose-related manner in both male and female rats; the incidence of this effect was markedly higher in female rats, which had higher blood levels of omeprazole. Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with 13.8 mg omeprazole/kg/day (about 3.4 times a human dose of 40 mg/day, based on body surface area) for one year, and then followed for an additional year without the drug. No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of one year (94% treated vs. 10% controls). By the second year the difference between treated and control rats was much smaller (46% vs. 26%) but still showed more hyperplasia in the treated group. Gastric adenocarcinoma was seen in one rat (2%). No similar tumor was seen in male or female rats treated for two years. For this strain of rat no similar tumor has been noted historically, but a finding involving only one tumor is difficult to interpret. In a 52-week toxicity study in Sprague-Dawley rats, brain astrocytomas were found in a small number of males that received omeprazole at dose levels of 0.4, 2, and 16 mg/kg/day (about 0.1 to 3.9 times the human dose of 40 mg/day, based on a body surface area basis). No astrocytomas were observed in female rats in this study. In a 2-year carcinogenicity study in Sprague-Dawley rats, no astrocytomas were found in males or females at the high dose of 140.8 mg/kg/day (about 34 times the human dose of 40 mg/day on a body surface area basis). A 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive. A 26-week p53 (+/-) transgenic mouse carcinogenicity study was not positive. u00a0
Omeprazole was positive for clastogenic effects in an in vitro human lymphocyte chromosomal aberration assay, in one of two in vivo mouse micronucleus tests, and in an in vivo bone marrow cell chromosomal aberration assay. Omeprazole was negative in the in vitro Ames test, an in vitro mouse lymphoma cell forward mutation assay, and an in vivo rat liver DNA damage assay. Omeprazole at oral doses up to 138 mg/kg/day in rats (about 34 times an oral human dose of 40 mg on a body surface area basis) was found to have no effect on fertility and reproductive performance.
In 24-month carcinogenicity studies in rats, a dose-related significant increase in gastric carcinoid tumors and ECL cell hyperplasia was observed in both male and female animals [see ]. Carcinoid tumors have also been observed in rats subjected to fundectomy or long-term treatment with other proton pump inhibitors or high doses of H-receptor antagonists.

No data

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standardu2014Tenth Edition. CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania, 19087, USA 2015.

Product: 53002-1104
NDC: 53002-1104-3 30 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 53002-1104-6 60 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 53002-1104-0 100 CAPSULE, DELAYED RELEASE in a BOTTLE
NDC: 53002-1104-9 15 CAPSULE, DELAYED RELEASE in a BOTTLE

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Adverse Reactions
Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with:
u2022 Hypersensitivity reactions [see ].
u2022 Acute Interstitial Nephritis [see ].
u2022 Clostridium difficile Associated Diarrhea [see ].
u2022 Bone Fracture [see ].
u2022 Cutaneous and Systemic Lupus Erythematosus [see ].
u2022 Cyanocobalamin (Vitamin B-12) Deficiency [see ].
u2022 Hypomagnesemia [see . u00a0
Drug Interactions
Advise patients to report to their healthcare provider if they start treatment with clopidogrel, St. Johnu2019s Wort or rifampin; or, if they take high-dose methotrexate [see Warnings and Precautions (, ,u00a0)]. u00a0
Administration
u2022 Take omeprazole delayed-release capsules before meals.
u2022 Antacids may be used concomitantly with omeprazole delayed-release capsules.
u2022 Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
Omeprazole Delayed-Release Capsules
u2022 Swallow omeprazole delayed-release capsules whole; do not chew.
u2022 For patients unable to swallow an intact capsule, omeprazole delayed-release capsules can be opened and administered in applesauce, as described in the Medication Guide.

MEDICATION GUIDEn- Array
Omeprazole Delayed-Release Capsules, USPn- Array
(oh mep' ra zole)
Read this Medication Guide before you start taking omeprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. u00a0
What is the most important information I should know about omeprazole delayed-release capsules?
Omeprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. u00a0
Omeprazole delayed-release capsules can cause serious side effects, including:
u2022 Some people who take proton pump inhibitor (PPI) medicines, including omeprazole delayed-release capsules, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with omeprazole delayed-release capsules. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine.
u2022 Omeprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
u2022 People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take omeprazole delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take omeprazole delayed-release capsules.
u2022 . Lupus erythematosus is an autoimmune disorder (the bodyu2019s immune cells attack other cells or organs in the body). Some people who take proton PPI medicines, including omeprazole delayed-release capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. u00a0
Omeprazole delayed-release capsules can have other serious side effects. See u201cWhat are the possible side effects of omeprazole delayed-release capsules?u201d u00a0
What are omeprazole delayed-release capsules?
Omeprazole delayed-release capsules are prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduce the amount of acid in your stomach. u00a0 u00a0
Omeprazole delayed-release capsules are used in adults:
u2022 for up to 8 weeks for the healing of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach.
u2022 with certain antibiotics for 10 to 14 days to treat an infection caused by bacteria called If needed, your doctor may decide to prescribe another 14 to 18 days of omeprazole delayed-release capsules by itself after the antibiotics. Sometimes bacteria can cause duodenal ulcers. The infection needs to be treated to prevent the ulcers from coming back.
u2022 for up to 8 weeks for healing stomach ulcers.
u2022 for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste, or burping.
u2022 for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). If needed, your doctor may decide to prescribe another 4 weeks of omeprazole delayed-release capsules.
u2022 to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules are safe and effective when used for longer than 12 months (1 year) for this purpose.
u2022 for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome. u00a0
For children 2 to 16 years of age, omeprazole delayed-release capsules are used:
u2022 for up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD).
u2022 for up to 8 weeks to treat gastroesophageal reflux disease (GERD) with acid-related damage to the lining of the esophagus [called erosive esophagitis (or EE) due to acid-mediated GERD].
u2022 to maintain healing of the esophagus. It is not known if omeprazole delayed-release capsules are safe and effective when used longer than 12 months (1 year) for this purpose. u00a0
Who should not take omeprazole delayed-release capsules?
Do not take omeprazole delayed-release capsules if you:
u2022 are allergic to omeprazole or any of the ingredients in omeprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in omeprazole delayed-release capsules.
u2022 are allergic to any other proton pump inhibitor (PPI) medicine.
u2022 are taking a medicine that contains rilpivirine (EDURANT, COMPLERA) used to treat HIV-1 (Human Immunodeficiency Virus). u00a0 u00a0
What should I tell my doctor before taking omeprazole delayed-release capsules?
Before taking omeprazole delayed-release capsules, tell your doctor about all of your medical conditions, including if you:
u2022 have been told that you have low magnesium levels in your blood
u2022 have liver problems
u2022 have any other medical conditions
u2022 are pregnant or plan to become pregnant. It is not known if omeprazole delayed-release capsules will harm your unborn baby.
u2022 are breastfeeding or plan to breastfeed. Omeprazole delayed-release capsules passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take omeprazole delayed-release capsules.
u2022 including prescription and over-the-counter medicines, vitamins and herbal supplements. Omeprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how omeprazole delayed-release capsules works. Especially tell your doctor if you take an antibiotic that contains clarithromycin or amoxicillin, or if you take clopidogrel (Plavix), methotrexate (Otrxup, Rasuvo, Trexall), St. Johnu2019s Wort (Hypericum perforatum), or rifampin (Rimactane, Rifater, Rifamate). u00a0
Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. u00a0
How should I take omeprazole delayed-release capsules?
u2022 Take omeprazole delayed-release capsules exactly as prescribed by your doctor.
u2022 Do not change your dose or stop omeprazole delayed-release capsules without talking to your doctor. u2022 Omeprazole delayed-release capsules are usually taken 1 time each day. Your doctor will tell you the time of day to take omeprazole delayed-release capsules, based on your medical condition.
u2022 Take omeprazole delayed-release capsules before a meal.
u2022 Antacids may be taken with omeprazole delayed-release capsules. u00a0
Omeprazole Delayed-Release Capsules
u2022 Swallow omeprazole delayed-release capsules whole. Do not chew or crush omeprazole delayed-release capsules.
u2022 If you have trouble swallowing a whole capsule, you can open the capsule and take the contents in applesauce. See the u201cInstructions for Useu201d at the end of this Medication Guide for instructions on how to take omeprazole delayed-release capsules with applesauce. u00a0
If you miss a dose of omeprazole delayed-release capsules, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take 2 doses at the same time to make up for the missed dose. u00a0
If you take too much omeprazole delayed-release capsules, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room. u00a0
What are the possible side effects of omeprazole delayed-release capsules?
Omeprazole delayed-release capsules can cause serious side effects, including:
u2022 See u201cWhat is the most important information I should know about omeprazole delayed-release capsules?u201d
u2022 Vitamin B-12 deficiency. Omeprazole delayed-release capsules reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B-12 properly. Talk with your doctor about the possibility of vitamin B-12 deficiency if you have been on omeprazole delayed-release capsules for a long time (more than 3 years).
u2022 Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a PPI medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. u00a0
You may or may not have symptoms of low magnesium. n
Your doctor may check the level of magnesium in your body before you start taking omeprazole delayed-release capsules or during treatment if you will be taking omeprazole delayed-release capsules for a long period of time.
The most common side effects with n- omeprazole delayed-release capsulesn- in adults and children include:
In addition to the side effects listed above, the most common side effects in children 2 to 16 years of age include:
Other side effects:
Serious allergic reactions.
Your doctor may stop omeprazole delayed-release capsules if these symptoms happen. Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects with omeprazole delayed-release capsules. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088n
Arrayn- Array
Array
u2022 Keep the container of omeprazole delayed-release capsules closed tightly.
u2022 Keep the container of omeprazole delayed-release capsules dry and away from light. u00a0
Keep omeprazole delayed-release capsules and all medicines out of the reach of children.
General information about the safe and effective use of omeprazole delayed-release capsules.
This Medication Guide summarizes the most important information about omeprazole delayed-release capsules. For more information, ask your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.
What are the ingredients in n- omeprazole delayed-release capsules? n- Array
Active ingredient in Omeprazole Delayed-Release Capsules: n- Array
Inactive ingredients in omeprazole delayed-release capsules
The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide.
For more information, call 1-888-375-3784.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USEn- Array
Omeprazole Delayed-Release Capsules, USPn- Array
(oh mep' ra zole)n- Array
Taking omeprazole delayed-release capsules with applesauce:
1. Place 1 tablespoon of applesauce into a clean container.
2. Carefully open the capsule and sprinkle the pellets onto the applesauce. Mix the pellets with the applesauce.
3. Swallow the applesauce and pellet mixture right away. Do not chew or crush the pellets. Do not store the applesauce and pellet mixture for later use.
Rx Only
Manufactured by: n
Dr. Reddyu2019s Laboratories Limited
Bachupally u2013 500 090 INDIA
Revised: 0117
Dispense with medication guide available at :
www.drreddys.com/medguide/omeprazoledrcaps.pdf
u00a0

No data

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Omeprazole (Omeprazole)

Trade Name : Omeprazole

CAPSULE, DELAYED RELEASE

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Omeprazole (Omeprazole)

Trade Name : Omeprazole

CAPSULE, DELAYED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

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