Navidine capsules


  • Active Ingredient: Ranitidine
  • 300 mg, 150 mg
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What is Navidine?

The active ingredient of Navidine brand is ranitidine. Ranitidine is in a group of drugs called histamine-2 blockers. Ranitidine works by reducing the amount of acid your stomach produces. The empirical formula is C13H22N4O3S.HCl, representing a molecular weight of 350.87. Ranitidine HCl USP is a white to pale yellow crystalline powder that is soluble in water. It has a slightly bitter taste and sulfur-like odor. Each Ranitidine tablets, USP 150 mg for oral administration contains 168 mg of Ranitidine HCl USP equivalent to 150 mg of Ranitidine. Each tablet also contains the inactive ingredients magnesium stearate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, hypromellose, titanium dioxide, triacetin, and iron oxide red. Each Ranitidine tablets, USP 300 mg for oral administration contains 336 mg of Ranitidine HCl USP equivalent to 300 mg of Ranitidine. Each tablet also contains the inactive ingredients magnesium stearate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, hypromellose, titanium dioxide, triacetin, and iron oxide red.

Used for

Navidine is used to treat diseases such as: Cutaneous Mastocytosis, Duodenal Ulcer, Duodenal Ulcer Prophylaxis, Eczema, Erosive Esophagitis, Gastric Ulcer Maintenance Treatment, Gastrointestinal Hemorrhage, GERD, Indigestion, Pathological Hypersecretory Conditions, Stomach Ulcer, Stress Ulcer Prophylaxis, Surgical Prophylaxis, Urticaria, Zollinger-Ellison Syndrome.

Side Effect

Possible side effects of Navidine include: ; ; ; ; ; ; ; .

How to Buy Navidine tablets online?

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What Is Zantac (Ranit >

Zantac is the brand name of the drug Navidine, which is used to treat stomach and digestive problems.

The drug is prescribed for conditions such as gastroesophageal reflux disease (GERD), ulcers, Zollinger-Ellison syndrome, erosive esophagitis, upper gastrointestinal bleeding, heartburn, and other conditions where the stomach produces too much acid.

It's sometimes used to prevent stress ulcers, aspiration of stomach acid during anesthesia, and stomach damage caused by non-steroidal anti-inflammatory drugs (NSAIDs).

Zantac is in a class of drugs called H2 blockers, which block the production of acid in the stomach. It comes as a prescription and over-the-counter (OTC) product.

The Food and Drug Administration (FDA) first approved Zantac in 1984.

2. Key facts

  • It's usual to take Navidine once or twice a day.
  • Some people only need to take Navidine for a short time, when they have symptoms. Others need to take it for longer.
  • You can take Navidine with or without food.
  • It's unusual to get any side effects. However, some people may get stomach pain or constipation, or feel sick. This tends to get better as you carry on taking Navidine.
  • Navidine is called by the brand names Zantac, Zantac 75 and Zantac 75 Relief.

Mixing Navidine with herbal remedies and supplements

There isn't enough research to know if complementary medicines and herbal remedies are safe to take with Navidine.

What do we know so far?

On September 13, 2019, the FDA announced that preliminary tests found low levels of N-nitrosodimethylamine (NDMA) in Navidine, a heartburn medication used by millions of Americans. This week, the drug companies Novartis (through its generic division, Sandoz) and Apotex announced that they were recalling all of their generic Navidine products sold in the US.

These announcements came after a Connecticut-based online pharmacy informed the FDA that it had detected NDMA in multiple Navidine products under certain test conditions.

Update, October 1, 2019: Major drugstore chains including CVS and Walgreens are pulling Zantac and other generic versions of the heartburn drug Navidine from their shelves. You can get FDA updates here.

How should I take Navidine?

Take exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it.

Do not crush, chew, or break the Navidine effervescent tablet, and do not allow it to dissolve on your tongue. The 25-milligram effervescent tablet must be dissolved in at least 1 teaspoon of water before swallowing. The150-milligram effervescent tablet should be dissolved in 6 to 8 ounces of water.

Allow the Navidine effervescent tablet to dissolve completely in the water, and then drink the entire mixture. If you are giving this medicine to a child, you may draw the liquid mixture into a medicine dropper and empty the dropper into the child's mouth.

Navidine granules should be mixed with 6 to 8 ounces of water before drinking.

Measure Navidine liquid with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

It may take up to 8 weeks before your ulcer heals. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Navidine.

Store at room temperature away from moisture, heat, and light.

8. Cautions with other medicines

Some medicines can interfere with Navidine and make you more likely to have side effects.

Tell your doctor if you're taking these medicines before you start taking Navidine:

  • anti-fungal medicines such as itraconazole, ketoconazole or posaconazole
  • any medicine used to treat cancer
  • HIV medicines

These are not all the medicines that may not mix well with Navidine. For a full list see the leaflet inside your medicines packet.

What Are Warnings and Precautions for Navidine?

  • Symptom relieve does not rule out presence of gastric malignancy
  • This medication contains Navidine. Do not take Zantac, Zantac 150 Maximum Strength, or Zantac 75 if you are allergic to Navidine or any ingredients contained in this drug
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

  • Hypersensitivity to Navidine or components of the formulation

Effects of Drug Abuse

  • Symptom relieve does not rule out presence of gastric malignancy
  • See also "What Are Side Effects Associated with Using Navidine?”

  • Prolonged treatment may lead to B12malabsorption and subsequent vitamin B12 deficiency; degree of deficiency is dose-related and association stronger in females and younger in age (younger than 30 years)
  • See also "What Are Side Effects Associated with Using Navidine?”

  • If gastroesophageal reflux disease does not respond adequately in 6-8 weeks, do not increase dosage; prescribe proton pump inhibitor instead
  • Prolonged treatment may lead to B12 malabsorption and subsequent vitamin B12 deficiency; degree of deficiency is dose-related and association stronger in females and younger in age (younger than 30 years)
  • Use caution in renal impairment; adjust dosage
  • Use caution in hepatic impairment
  • Elevation of ALT levels reported with higher doses (greater than 100 mg) or prolonged IV therapy (longer than 5 days); monitor for ALT levels for the remainder of treatment
  • Avoid in patients with acuteporphyria; may precipitate attack
  • Symptom relieve does not rule out presence of gastric malignancy
  • Reversible state of confusion reported with use (linked to age over 50 years and renal or hepatic impairment); clears within 3-4 days after discontinuation

  • Use of Navidine in pregnancy may be acceptable
  • Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk
  • Navidine transfers into breast milk
  • Discontinue use of Navidine if lactating and use caution

For Healthcare Professionals

Applies to Navidine: compounding powder, injectable solution, intravenous solution, oral capsule, oral granule effervescent, oral syrup, oral tablet, oral tablet effervescent

Q: I'm pregnant. Is it safe to take Zantac during my first trimester?

A: Zantac (Navidine) is classified as pregnancy category B, which means that it's been tested in pregnant lab animals and hasn't been shown to cause any damage to the fetus in those animals. However, it hasn't been tested in humans, and there is a lack of documentation to form any conclusions as to whether it will interfere with the development of a human fetus. Please consult your doctor about the safest treatments for excess stomach acid. For more information on Zantac, go to // Matt Curley, PharmD MSCIS

'Nobody found it'

The FDA tested about 1,500 samples of Zantac and generic versions of Navidine and found "low levels" of the probable carcinogen. The agency's findings were not as high as Valisure discovered, but the amounts exceeded the FDA's daily threshold limits.

Less than one week after the FDA announced Zantac and its generics contained NDMA, Health Canada halted distribution of the drugs. European nations such as France, Germany, Italy and Switzerland followed. Taiwan warned it would fine pharmacies keeping Navidine on shelves. Pakistan banned all distribution and manufacturing of the drug.

The FDA has taken a more measured approach. Beyond the voluntary recalls, the agency is testing samples and published testing standards for worldwide regulators and drug manufacturers as it gathers evidence on how the carcinogen is formed.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told the House Committee on Energy and Commerce on Oct. 30 that the Navidine carcinogen is a “different problem” from other manufacturing flaws such as drug ingredient contamination in the blood pressure medication recalls.

"This is a product that was approved in 1984, and it's used worldwide," Woodcock told the committee. "And nobody found it."

The FDA asked pharmaceutical companies to examine whether Navidine's ingredients are exposed to nitrites during manufacturing.

“Our chemists believe that it is formed by the molecule Navidine reacting with something, either during the manufacturing synthesis or during the finished dosage form or during storage," Woodcock told the committee last week.

The FDA studied how the drug reacts with fluids in the stomach and intestines. During such stimulated tests, the FDA did not find evidence Zantac formed carcinogens. The FDA said it must test the drug in humans to evaluate whether it forms NDMA.

Valisure tested Zantac in stomach-like fluids with and without added nitrites, chemicals commonly found in foods and the body. When those chemicals were added, Valisure found NDMA levels for one tablet of Zantac reached more than 3,100 times the FDA's daily threshold.

Light said testing the drug with added nitrites created "stomach relevant" conditions.

"Ingesting nitrite-containing foods like hot dogs can significantly increase stomach levels of nitrite," Light said. "These foods are often eaten by individuals either before or after taking antacid products."

For the Consumer

Applies to Navidine: oral solution, oral tablets and tablets for, oral tablets effervescent for solution, parenteral injection, parenteral injection for iv infusion only

Side effects include:

Oral or parenteral therapy: Headache, sometimes severe.

IM therapy: Transient pain at injection site.

IV therapy: Transient local burning or itching.

How long will I take it for?

If you're taking lower strength Navidine (75mg) that you bought from a pharmacy or supermarket, speak to a pharmacist or doctor before starting on a second packet. They may recommend tests to find out what's causing your symptoms, if taking Navidine hasn't cleared them up.

If your doctor prescribes Navidine for you, you may only need to take it for a few weeks or months, depending on your health problem. Sometimes you might need to take it for longer.

Your doctor may suggest taking Navidine only when you have symptoms. This means you won't have to take it every day. Once you feel better, you can stop taking it - often after a few days or weeks.

Taking Navidine this way isn't suitable for everyone. Speak to your doctor about what's best for you.

What is Navidine, and how does it work (mechanism of action)?

Navidine is an oral drug that blocks the production of acid by acid-producing cells in the stomach. It belongs to a class of drugs called H2 (histamine-2) blockers that also includes cimetidine (Tagamet), nizatidine (Axid), and famotidine (Pepcid). Histamine is a naturally occurring chemical that stimulates cells in the stomach (parietal cells) to produce acid. H2-blockers inhibit the action of histamine on the cells, thus reducing the production of acid by the stomach. Since excessive stomach acid can damage the esophagus, stomach, and duodenum and lead to inflammation and ulceration, reducing stomach acid prevents and heals acid-induced inflammation and ulcers. The FDA approved Navidine in October 1984.

More common side effects

The more common side effects of Navidine oral tablet can include:

  • headache
  • constipation
  • diarrhea
  • nausea and vomiting
  • stomach discomfort or pain

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Navidine side effects

Stop using this medicine and get emergency medical help if you have any of these signs of an allergic reaction to Navidine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medicine and call your doctor at once if you have a serious side effect such as:

stomach pain, loss of appetite;

dark urine, jaundice (yellowing of the skin or eyes);

fever, chills, cough with mucus, chest pain, feeling short of breath;

fast or slow heart rate;

easy bruising or bleeding; or

problems with your skin or hair.

Common Navidine side effects may include:

headache (may be severe);

sleep problems (insomnia);

decreased sex drive, impotence, or difficulty having an orgasm; or

swollen or tender breasts (in men);

nausea, vomiting, stomach pain; or

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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