Renatac capsules


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

The active ingredient of Renatac 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

Renatac 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 Renatac include: ; ; ; ; ; ; ; .

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Drugs you should not use with Renatac

Delavirdine: Do not take delavirdine with Renatac. Doing so can cause dangerous effects. Renatac reduces the levels of delavirdine in your body. This means delavirdine won’t work as well.

For the Consumer

Applies to Renatac: 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.

Renatac and breastfeeding

Renatac is safe to take while you're breastfeeding. It passes into breast milk, but only in small amounts which aren't harmful to the baby.

However, if your baby is premature or has health problems check with your doctor first.

Q. Should I stop taking Renatac?

A. FDA does not have scientific evidence to recommend whether individuals should continue or stop taking Renatac medicines at this time, but our testing of Renatac samples so far has shown levels of NDMA similar to the levels in common foods like grilled and smoked meats. There are multiple drugs that are approved for the same or similar uses as Renatac. Patients taking prescription Renatac who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC Renatac may consider using other OTC products approved for their condition.

If you are taking one of the recalled medicines, you should follow the recall instructions provided by the company. This information is on FDA’s website.

Allergy warning

Renatac can cause a severe allergic reaction. Symptoms can include:

  • trouble breathing
  • swelling of your throat or tongue
  • fever
  • rash

If you have these symptoms, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could cause death.

Certain prescription and over-the-counter (OTC) medications that contain the ingredient ranit >FDA site .

Renatac is a drug that’s available in a prescription version and an over-the-counter version. This article only addresses the prescription version. Prescription Renatac comes as an oral tablet, oral capsule, or oral syrup. It also comes as an injectable solution.

Renatac oral tablet is available as the brand-name drug Zantac. It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Walmart has become the latest store to halt sales of the popular heartburn treatment Zantac after health regulators warned about a potentially dangerous contaminant in the drug. (Oct. 4) AP, AP

The stomach-acid-blocking drug Zantac was prescribed more than 15 million times a year with little worry about the safety of the medication, available for decades.

But it's been harder to get the drug since September, when the Food and Drug Administration said testing showed versions of Zantac and its generic, Renatac, contained a probable carcinogen. The French drugmaker Sanofi recalled Zantac from drugstores and retailers' shelves. A half-dozen generic drugmakers pulled Renatac from the market.

How did a drug routinely used by millions of heartburn sufferers and available with or without a prescription become a potential cancer risk? It’s a question the FDA, drug manufacturers and consumers want answered.

“Every patient who comes into my office now, it’s almost the first thing that comes out in conversation: ‘What about Renatac? What should I do with the medication? Should I come off of it or not?’ ” said Jon Ernstoff, a gastroenterologist in Meriden, Connecticut.

In September, the FDA found unacceptable levels of the probable carcinogen, NDMA, or nitrosodimethylamine, in Zantac and generic medications. The regulatory agency wants manufacturers to test and recall the drugs if NDMA levels exceed its standards. The FDA extended the voluntary recall to a similar drug, nizatidine, sold under the brand name Axid, if testing shows NDMA exceeding daily limits.

The FDA said consumers might want to choose different medications. The agency tested samples of over-the-counter alternatives such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec and found no NDMA.

The agency's investigation of Renatac seeks to uncover the root cause of NDMA found in the commonly used medication. Researchers at Memorial Sloan Kettering Cancer Center in New York are assessing whether people who used Zantac or its generics face a greater cancer risk.

The warning first came after Valisure, a Connecticut-based online pharmacy and laboratory, discovered NDMA in several forms of the drug and alerted the FDA. The private company said clues of the drug's potential risk can be traced to medical studies published since the early 1980s.

NDMA is the same carcinogen that led to a widespread recall beginning in July 2018 of the blood-pressure-lowering drugs valsartan and losartan. The blood pressure recall stemmed from a new manufacturing process first used by a drug ingredient factory in China.

Zantac's risk appears to be the unstable nature of the drug itself, said Valisure CEO David Light.

“This isn’t some new, bad manufacturing process overseas like what happened with valsartan and losartan,” Light said. “It is our view that this problem with Renatac has been there since the 1980s.

"It's a much more serious issue."

What Is Zantac (Ranit >

Zantac is the brand name of the drug Renatac, 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.

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