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Cimetidine 400 Mg Tabs 100 By Teva Pharma

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Cimetidine 400 Mg Tabs 100 By Teva Pharma

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Cimetidine 400 Mg Tabs 100 By Teva Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3581402/RXB10091129/RXA312272
Size : 100
Selling UoM : EA
NDC: 00093-8204-01
UPC Barcode : 300938204014
Supplier: 0050001781 TEVA PHARMACEUTICALS USA
Supplier Material : 820401
Generic Code : 011667 CIMETIDINE ORAL TABLET 400 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : GRX Generic RX

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Product Description.:

N 204, 400
tablet , film-coated , green , scored , oval oblong
Debossed

Tagamet (cimetidine) is a histamine H2-receptor antagonist. Cimetidine contains an imidazole ring, and is chemically related to histamine.

(The liquid and injection dosage forms contain cimetidine as the hydrochloride.)

Cimetidine has a bitter taste and characteristic odor.

Solubility Characteristics : Cimetidine is soluble in alcohol, slightly soluble in water, very slightly soluble in chloroform and insoluble in ether. Cimetidine hydrochloride is freely soluble in water, soluble in alcohol, very slightly soluble in chloroform and practically insoluble in ether.

Tablets for Oral Administration : Each light green, film-coated tablet contains cimetidine as follows: 300 mg-round, debossed with the product name TAGAMET, SB and 300 400 mg-oval Tiltab? tablets, debossed with the product name TAGAMET, SB and 400 800 mg-oval Tiltab? tablets, debossed with the product name TAGAMET, SB and 800. Inactive ingredients consist of cellulose, D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, hydroxypropyl methylcellulose, iron oxides, magnesium stearate, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, starch, titanium dioxide and trace amounts of other inactive ingredients.

Liquid for Oral Administration : Each 5 mL (1 teaspoonful) of clear, light orange, mint-peach flavored liquid contains cimetidine hydrochloride equivalent to cimetidine, 300 mg alcohol, 2.8%. Inactive ingredients consist of FD&C Yellow No. 6, flavors, methylparaben, polyoxyethylene polyoxypropylene glycol, propylene glycol, propylparaben, saccharin sodium, sodium chloride, sodium phosphate, sorbitol and water.

Injection

Single-Dose Vials for Intramuscular or Intravenous Administration : Each 2 mL contains, in sterile aqueous solution (pH range 3.8 to 6), cimetidine hydrochloride equivalent to cimetidine, 300 mg phenol, 10 mg.

Multi-Dose Vials for Intramuscular or Intravenous Administration : 8 mL (300 mg/2 mL): Each 2 mL contains, in sterile aqueous solution (pH range 3.8 to 6), cimetidine hydrochloride equivalent to cimetidine, 300 mg phenol, 10 mg.

Single-Dose Premixed Plastic Containers for Intravenous Administration : Each 50 mL of sterile aqueous solution (pH range 5 to 7) contains cimetidine hydrochloride equivalent to 300 mg cimetidine and 0.45 grams sodium chloride.

No preservative has been added.

The plastic container is fabricated from specially formulated polyvinyl chloride. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di 2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers as well as by tissue culture toxicity studies.

ADD-Vantage?* Vials for Intravenous Administration : Each 2 mL contains, in sterile aqueous solution (pH range 3.8 to 6), cimetidine hydrochloride equivalent to cimetidine, 300 mg phenol, 10 mg.

All of the above injection formulations are pyrogen free, and sodium hydroxide N.F. is used as an ingredient to adjust the pH.

INDICATIONS

Tagamet (cimetidine) is indicated in:

(1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use Tagamet at full dosage for longer than 6 to 8 weeks (see Dosage and Administration-Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of Tagamet and antacids is not recommended, since antacids have been reported to interfere with the absorption of Tagamet.

(2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with Tagamet 400 mg h.s. for periods of up to 5 years.

(3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks.

(4) Erosive gastroesophageal reflux disease (GERD). Erosive esophagitis diagnosed by endoscopy. Treatment is indicated for 12 weeks for healing of lesions and control of symptoms. The use of Tagamet beyond 12 weeks has not been established (see Dosage and Administration-GERD).

(5) Prevention of upper gastrointestinal bleeding in critically ill patients.

(6) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosi