Omeprazole (Omeprazole)

Trade Name : omeprazole

Camber Pharmaceuticals, Inc.

CAPSULE, DELAYED RELEASE

Strength 10 mg/1

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

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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 Camber Pharmaceuticals, Inc.. It is available in strength of 10 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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Warnings and Precautions, Fundic Gland Polyps ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 06/2018

Omeprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the: u2022u00a0Treatment of active duodenal ulcer in adults () u2022u00a0Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults () u2022u00a0Treatment of active benign gastric ulcer in adults () u2022u00a0Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older () u2022u00a0Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older () u2022u00a0Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older () u2022u00a0Pathologic hypersecretory conditions in adults ()

* if ulcer present, continue omeprazole delayed-release capsules 20 mg once daily for an additional 18u00a0 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 orange opaque cap/orange opaque body sizeu00a0 '3' u00a0hard gelatin capsule imprinted with 'H' on cap and '73' on body with black ink, filled with white to off white pellets. Omeprazole Delayed-Release Capsules USP, 20 mg, are white opaque cap/blue opaque body size '2' hard gelatin capsule imprinted with 'H' on cap and '74' on body with black ink, filled with white to off white pellets.
u2022u00a0Omeprazole Delayed-Release Capsules: 10 mg and 20 mg ()

u2022u00a0Omeprazole delayed-release capsules are 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 n u2022u00a0Proton pump inhibitors (PPIs), including omeprazole delayed-release capsules, are contraindicated in patients receiving rilpivirine-containing products n u2022u00a0For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with omeprazole delayed-release capsules, refer to the CONTRAINDICATIONS section of their package inserts.
u2022u00a0Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation. () u2022u00a0Patients receiving rilpivirine-containing products. (, ) u2022u00a0Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with omeprazole delayed-release capsules. ()

u2022u00a0: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. () u2022u00a0 Observed in patients taking PPIs. () u2022u00a0 PPI therapy may be associated with increased risk. () u2022u00a0 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. () u2022u00a0 Mostly cutaneous; new onset or exacerbation of existing disease; discontinue omeprazole and refer to specialist for evaluation() u2022u00a0 Avoid concomitant use of omeprazole. (, ) u2022u00a0 Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. () u2022u00a0 Reported rarely with prolonged treatment with PPIs. () u2022u00a0 Avoid concomitant use of omeprazole. (,) u2022: Increased Chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors; temporarily stop omeprazole at least 14 days before assessing CgA levels. (, ) u2022 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. (, ) u2022u00a0 Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. ()

The following serious adverse reactions are described below and elsewhere in labeling: u2022u00a0Acute Interstitial Nephritis n u2022-Associated Diarrhea n u2022u00a0Bone Fracture n u2022u00a0Cutaneous and Systemic Lupus Erythematosus n u2022u00a0Cyanocobalamin (Vitamin B-12) Deficiency n n n u2022u00a0Hypomagnesemia n u2022u00a0Fundic Gland Polyps n
Adults: Most common adverse reactions in adults (incidence u2265 2%) are u2022 Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. () u00a0Pediatric patients (2 to 16 years of age): u2022u00a0Safety profile similar to that in adults, except that respiratory system events and fever were the most frequently reported reactions in pediatric studies. () n n n

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. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. n n
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. ()

No data

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 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. 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, USP 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 USP is a white to off-white powder that melts with decomposition at about 150u00b0C to 160u00b0C. Soluble in dichloromethane, sparingly soluble in methanol and in alcohol. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg or 20 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: colloidal silicon dioxide, dibasic sodium phosphate anhydrous, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, lactose monohydrate, low-substituted hydroxypropyl cellulose, mannitol, microcrystalline cellulose, sodium lauryl sulphate, talc and triethyl citrate. The capsule shells have the following inactive ingredients: D&C Red 28, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide. The imprinting ink contains the following ingredients black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. FDA approved dissolution test specifications differ from the USP.

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 au00a0dose-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. Omeprazole was positive for clastogenic effects in an human lymphocyte chromosomal aberration assay, in one of two mouse micronucleus tests, and in an bone marrow cell chromosomal aberration assay. Omeprazole was negative in the Ames test, an mouse lymphoma cell forward mutation assay, and an 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 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.u00a0Clinical and Laboratory Standards Institute (CLSITenth Edition. CLSI Document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania, 19087, USA 2015.

Omeprazole delayed-release capsules, USP 10 mg, are orange opaque cap/orange opaque body size '3' hard gelatin capsule imprinted with 'H' on cap and '73' on body with black ink, filled with white to off white pellets. They are supplied as follows:
Bottles of 30 capsulesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 31722-527-30 Bottles of 100 capsulesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 31722-527-01
Omeprazole delayed-release capsules, USP 20 mg, are white opaque cap/blue opaque body size '2' hard gelatin capsule imprinted with 'H' on cap and '74' on body with black ink, filled with white to off white pellets. They are supplied as follows:
Bottles of 30 capsulesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 31722-528-30 Bottles of 100 capsulesu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 31722-528-01n n Store omeprazole delayed-release capsules in a tight container protected from light and moisture. Omeprazole delayed-release capsules should be stored at 20u00b0to 25u00b0C (68 to 77u00b0F)[see USP Controlled Room Temperature].

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). n n Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: u2022u00a0Hypersensitivity reactions n u2022u00a0Acute Interstitial Nephritisn u2022u00a0Clostridium difficile-Associated Diarrhean u2022u00a0Bone Fracturen u2022u00a0Cutaneous and Systemic Lupus Erythematosus n u2022u00a0Cyanocobalamin (Vitamin B-12) Deficiency n u2022u00a0Hypomagnesemia n n n Advise patients to report to their healthcare provider if they start treatment with clopidogrel, St. John's Wort or rifampin; or, if they take high-dose methotrexate n n n u2022u00a0Take omeprazole delayed-release capsules before meals. u2022u00a0Antacids may be used concomitantly with omeprazole delayed-release capsules. u2022u00a0Missed 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. n n u2022u00a0Swallow omeprazole delayed-release capsules whole; do not chew. u2022u00a0For patients unable to swallow an intact capsule, omeprazole delayed-release capsules can be opened and administered in applesauce, as described in the Medication Guide.
Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854
By: n Hetero Labs Limited Jeedimetla, Hyderabad - 500 055, India
Revised: 10/2019

Omeprazole Delayed-Release Capsules, USP (oh mep' ra zole)n
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.n 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.n Omeprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection () in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. n 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. n 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. Omeprazole delayed-release capsules can have other serious side effects. n n n Omeprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Omeprazole delayed-release capsules reduce the amount of acid in your stomach. Omeprazole delayed-release capsules are used in adults: u2022u00a0 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. u2022u00a0 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. u2022u00a0u00a0 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. u2022u00a0 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. u2022u00a0 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. u2022u00a0 for the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome. 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). u2022u00a0 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]. u2022u00a0 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. u2022u00a0It is not known if omeprazole delayed-release capsules are safe and effective in children less than 1 month of age.
Who should not take omeprazole delayed-release capsules? Do not take omeprazole delayed-release capsules if you:n- What should I tell my doctor before taking omeprazole delayed-release capsules?u00a0 Before taking omeprazole delayed-release capsules, tell your doctor about all of your medical conditions, including if you:n- u2022 Tell your doctor about all of the medicines you taken- Hypericum perforatumn- How should I take omeprazole delayed-release capsules?n- Omeprazole Delayed-Release Capsulesn- Do not chew or crush omeprazole delayed-release capsules.n- What are the possible side effects of omeprazole delayed-release capsules? Omeprazole delayed-release capsules can cause serious side effects, includingn- u2022u00a0See ''What is the most important information I should know about omeprazole delayed-release capsules?'' u2022u00a0Vitamin B-12 deficiency.n- u2022u00a0Low magnesium levels in your body.n- u2022u00a0Stomach growths (fundic gland polyps).
You may or may not have symptoms of low magnesium. n
u2022u00a0seizures u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u2022jitterinessu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u2022spasms of the hands and feet u2022 dizzinessu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u2022 jerking movements or shaking (tremors) u00a0u00a0 u2022cramps or muscle aches
u2022 abnormal or fast heart beat u00a0u00a0u00a0u00a0u00a0 u2022muscle weakness u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u2022spasm of the voice box
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. n n
u2022 headache u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u2022 nauseau00a0u00a0u00a0u00a0u00a0 u00a0u2022 vomiting u2022 stomach painu00a0u00a0u00a0u00a0u00a0 u00a0u2022 diarrheau00a0u00a0u00a0u00a0 u00a0u2022 gas
In addition to the side effects listed above, the most common side effects in children 2 to 16 years of age include: u2022u00a0 respiratory system eventsu00a0u00a0u00a0 u2022u00a0 fever Other side effects: n Tell your doctor if you get any of the following symptoms with omeprazole delayed-release capsules: u2022 rashu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u2022 face swelling u2022 throat tightnessu00a0u00a0u00a0u00a0u00a0u2022 difficulty breathing 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-1088. n n u2022u00a0Store omeprazole delayed-release capsules at room temperature between 20u00b0 to 25u00b0Cu00a0 (68u00b0 to 77u00b0F). u2022u00a0Keep the container of omeprazole delayed-release capsules closed tightly. u2022u00a0Keep the container of omeprazole delayed-release capsules dry and away from light.
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.n- What are the ingredients in omeprazole delayed-release capsules? Active ingredient in Omeprazole Delayed-Release Capsules: n- Inactive ingredients in Omeprazole Delayed-Release Capsules:
All brands listed are the trademarks of their respective owners and are not trademarks of Hetero Labs Limited.
For more information, call Hetero Labs Limited at 1-866-495-1995.
This Medication Guide has been approved by the U.S. Food and Drug Administration. n Medication Guide available at n n n n n Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854n By:n Hetero Labs Limited Jeedimetla, Hyderabad - 500 055, Indian Revised: 10/2019
INSTRUCTIONS FOR USE Omeprazole Delayed-Release Capsules, USP (oh mep' ra zole)n n
Omeprazole Delayed-Release Capsules
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.

Omeprazole Delayed-release Capsules, USP - 10 mg 30s container label
Omeprazole Delayed-release Capsules, USP - 10 mg 30s container label

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Omeprazole (Omeprazole)

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