Zantac

DRUG DESCRIPTION

The active ingredient in ZANTAC (ranitidine hcl) 150 Tablets, ZANTAC (ranitidine hcl) 300 Tablets, ZANTAC (ranitidine hcl) 25 EFFERdose Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:

ZANTAC® 
(ranitidine hydrochloride) Structural Formula Illustration

The empirical formula is C13H22N4O3S•HCl, representing a molecular weight of 350.87.

Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor.

Each ZANTAC (ranitidine hcl) 150 Tablet for oral administration contains 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients FD&C Yellow No. 6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin, and yellow iron oxide.

Each ZANTAC (ranitidine hcl) 300 Tablet for oral administration contains 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients croscarmellose sodium, D&C Yellow No. 10 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

ZANTAC (ranitidine hcl) 25 EFFERdose Tablets for oral administration is an effervescent formulation of ranitidine that must be dissolved in water before use. Each individual tablet contains 28 mg of ranitidine HCl equivalent to 25 mg of ranitidine and the following inactive ingredients: aspartame, monosodium citrate anhydrous, povidone, and sodium bicarbonate. Each tablet also contains sodium benzoate. The total sodium content of each tablet is 30.52 mg (1.33 mEq) per 25 mg of ranitidine.

Each 1 mL of ZANTAC Syrup contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. ZANTAC (ranitidine hcl) Syrup also contains the inactive ingredients alcohol (7.5%), butylparaben, dibasic sodium phosphate, hypromellose, peppermint flavor, monobasic potassium phosphate, propylparaben, purified water, saccharin sodium, sodium chloride, and sorbitol.

What are the possible side effects of ranitidine?

Stop using ranitidine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain, fever, feeling short of breath, coughing up green or yellow mucus;
  • easy bruising or bleeding, unusual weakness;
  • fast or slow heart rate;
  • problems with your vision;
  • fever, sore throat, and headache with a severe blistering,...

Read All Potential Side Effects and See Pictures of Zantac »

What are the precautions when taking ranitidine hcl (Zantac)?

Before taking ranitidine, tell your doctor or pharmacist if you are allergic to it; or to other H2 histamine blockers (e.g., cimetidine, famotidine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain blood disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, kidney problems, liver problems, lung diseases (e.g., asthma, chronic obstructive pulmonary disease-COPD), other stomach problems (e.g.,...

Read All Potential Precautions of Zantac »


Zantac Consumer (continued)

SIDE EFFECTS: Headache, dizziness, constipation or diarrhea may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blurred vision, mental/mood changes (e.g., agitation, confusion, depression, hallucinations).

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, enlarged breasts, severe tiredness, fast/slow/irregular heartbeat, signs of infection (e.g., fever, persistent sore throat, cough), severe stomach/abdominal pain, dark urine, yellowing skin/eyes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ranitidine, tell your doctor or pharmacist if you are allergic to it; or to other H2 histamine blockers (e.g., cimetidine, famotidine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain blood disorder (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, kidney problems, liver problems, lung diseases (e.g., asthma, chronic obstructive pulmonary disease-COPD), other stomach problems (e.g., tumors).

Some symptoms may actually be signs of a more serious condition. Tell your doctor immediately if you have: heartburn combined with lightheadedness/sweating/dizziness, chest pain or shoulder/jaw pain (especially with trouble breathing), pain spreading to arms/neck/shoulders, unexplained weight loss.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Do not use to treat children younger than 12 unless directed by the doctor.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects while using this drug. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially confusion and dizziness.

Ranitidine should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

Ranitidine passes into breast milk. Consult your doctor before breast-feeding.


Zantac Patient Information Including Side Effects

Brand Names: Taladine, Zantac, Zantac 150, Zantac 300, Zantac 75, Zantac EFFERdose

Generic Name: ranitidine (Pronunciation: ra NI ti deen)

  • What is ranitidine (Zantac)?
  • What are the possible side effects of ranitidine?
  • What is the most important information I should know about ranitidine?
  • What should I discuss with my healthcare provider before using ranitidine?
  • How should I take ranitidine?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking ranitidine?
  • What other drugs will affect ranitidine?
  • Where can I get more information?

What is ranitidine (Zantac)?

Ranitidine is in a group of drugs called histamine-2 blockers. Ranitidine works by reducing the amount of acid your stomach produces.

Ranitidine is used to treat and prevent ulcers in the stomach and intestines. It also treats conditions in which the stomach produces too much acid, such as Zollinger-Ellison syndrome. Ranitidine also treats gastroesophageal reflux disease (GERD) and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

Ranitidine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ranitidine?

Stop using ranitidine and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • chest pain, fever, feeling short of breath, coughing up green or yellow mucus;
  • easy bruising or bleeding, unusual weakness;
  • fast or slow heart rate;
  • problems with your vision;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache (may be severe);
  • drowsiness, dizziness;
  • sleep problems (insomnia);
  • decreased sex drive, impotence, or difficulty having an orgasm; or
  • swollen or tender breasts (in men);
  • nausea, vomiting, stomach pain; or
  • diarrhea or constipation.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ranitidine?

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have kidney disease, liver disease, or porphyria.

Using ranitidine may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

Ranitidine granules and effervescent tablets must be dissolved in water before you take them.

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.

Avoid drinking alcohol. It can increase the risk of damage to your stomach.

It may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Heartburn can be confused with early symptoms of heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, dizziness, pain spreading to the arm or shoulder, sweating, nausea or vomiting, and a general ill feeling.

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