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ZANTAC Generic

(Ranitidine)

Indications:

Relieves heartburn associated with acid indigestion and sour stomach. Prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages.

Directions: Adults and children 12 years and over:

To relieve symptoms, swallow 1 tablet with a glass of water
To prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
can be used up to twice daily (up to 2 tablets in 24 hours)
children under 12 years: ask a doctor
store at 20°-25°C (68°-77°F)
avoid excessive heat or humidity



Ingredients: Active Ingredients: each tablet: Ranitidine 75mg (as Ranitidine Hydrochloride 84mg) (acid reducer)

Inactive Ingredients: Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Synthetic Red Iron Oxide, Titanium Dioxide, Triacetin


Warnings: Allergy Alert: Do not use if you are allergic to ranitidine or other acid reducers

Do not use:

if you have trouble swallowing
with other acid reducers

Stop use and ask a doctor if:

stomach pain continues
you need to take this product for more than 14 days
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.


 

DESCRIPTION

Ranitidine HCl - Zantac is 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, hydrochloride.

The empirical formula is C13H22N4O3SˇHCl, 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.

Oral

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, hydroxypropyl methylcellulose, 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, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.

Zantac 150 geldose capsules and Zantac 300 geldose capsules for oral administration are soft gelatin capsules containing 168 mg of ranitidine HCl equivalent to 150 mg of ranitidine and 336 mg of ranitidine HCl equivalent to 300 mg of ranitidine, respectively, in a nonaqueous matrix of synthetic coconut oil and synthetic triglycerides. The soft gelatin capsule shell contains gelatin, sorbitol special (sorbitol and sorbitol anhydrides), glycerin, purified water, titanium dioxide, FD&C yellow No. 6, FD&C blue No. 1, and FD&C red No. 40. The capsule shell may also contain mineral oil and soybean lecithin. The capsules are printed with edible ink.

Zantac 150 EFFERdose tablets and Zantac 150 EFFERdose granules for oral administration are effervescent formulations of ranitidine that must be dissolved in water before use. Each individual tablet or the contents of a packet contain 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, and the total sodium content of each packet of granules is 173.54 mg (7.55 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, hydroxypropyl methylcellulose, peppermint flavor, monobasic potassium phosphate, propylparaben, purified water, saccharin sodium, sodium chloride, and sorbitol.

Injection, Injection Premixed, and Injection Pharmacy Bulk PackagežNot for Direct Infusion

Ranitidine HCl Injection is a clear, colorless to yellow, nonpyrogenic liquid. The yellow color of the liquid tends to intensify without adversely affecting potency. The pH of the injection solution is 6.7 to 7.3.

Sterile Injection for Intramuscular or Intravenous Administration or Injection Pharmacy Bulk Package: Each 1 ml of aqueous solution contains ranitidine 25 mg (as the hydrochloride); phenol 5 mg as preservative; and 0.96 mg of monobasic potassium phosphate and 2.4 mg of dibasic sodium phosphate as buffers.

Injection Pharmacy Bulk PackagežNot for Direct Infusion:

A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous (IV) infusion.

Sterile, Premixed Solution for Intravenous Administration in Single-Dose, Flexible Plastic Containers: Each 50 ml contains ranitidine HCl equivalent to 50 mg of ranitidine, sodium chloride 225 mg, and citric acid 15 mg and dibasic sodium phosphate 90 mg as buffers in water for injection. It contains no preservatives. The osmolarity of this solution is 180 mOsm/l (approx.), and the pH is 6.7 to 7.3.

The flexible plastic container is fabricated from a specially formulated, nonplasticized, thermoplastic co-polyester (CR3). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of the chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
 

 

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