Zantac ( Ranitidine )
The active ingredient in ZANTAC 150 Tablets, ZANTAC 300 Tablets, ZANTAC 25 EFFERdose Tablets, ZANTAC 150 EFFERdose Tablets, and ZANTAC Syrup is ranitidine hydrochloride (HCl), USP, a histamine H2-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:
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 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 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 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.
ZANTAC 150 EFFERdose Tablets for oral administration is an effervescent formulation of ranitidine that must be dissolved in water before use. Each individual tablet contains 168 mg of ranitidine HCl equivalent to 150 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 183.12 mg (7.96 mEq) per 150 mg of ranitidine.
Each 1 mL of ZANTAC Syrup contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. ZANTAC 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.
Common uses
This medicine is a histamine blocker used to treat and prevent ulcers. It is also used to treat gastroesophageal reflux disease (gerd). This medicine may also be used to treat other conditions as determined by your doctor.
Before using
Additional monitoring of your dose or condition may be needed if you are taking certain cephalosporins (such as cefditoren or cefpodixime), itraconazole, or ketoconazole. Do not start or stop any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
Directions
Follow the directions for using this medicine provided by your doctor. Antacids may be used with this medicine unless directed otherwise by your doctor. Store this medicine at room temperature, away from heat and light. If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Cautions
If your symptoms do not improve or if they become worse, check with your doctor. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol, may lessen your ability to drive or to perform other potentially dangerous tasks. Before you begin taking any new medicine, either prescription or over-the-counter, check with your doctor or pharmacist. For women: this medicine is excreted in breast milk. If you are or will be breast-feeding while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.
Possible side effects
A side effect that may go away during treatment, is headache. If it continues, or is bothersome, check with your doctor. An allergic reaction to this medicine is unlikely, but seek immediate medical attnetion if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.
If you take too much
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include difficulty breathing, fast heartbeat, tremors, vomiting, and restlessness.
Additional information
Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children. If using this medicine for an extended period of time, obtain refills before your supply runs out.
Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Some medicines or medical conditions may interact with this medicine. Inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking.
