Amoxicillin 500 MG Oral Capsule
1 INDICATIONS AND USAGE Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli , Proteus mirabilis , or Enterococcus faecalis . Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae , Staphylococcus spp., or H. influenzae . Adult Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole: Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 ) Adults and Pediatric Patients ( 1 ) Upper Respiratory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adult Patients only ( 1 ) Helicobacter pylori Infection and Duodenal Ulcer Disease Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules and other antibacterial drugs, amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
Teva Pharmaceuticals USA Inc
CAPSULE BROWN TEVA 3109
TEVA 3109 CAPSULE BROWN
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16 HOW SUPPLIED/STORAGE AND HANDLING
AMOXICILLIN tablets, USP: 500 mg : Each tablet contains 500 mg of
AMOXICILLIN, USP as the trihydrate. Each film-coated, capsule-shaped, off-white, tablet is debossed with “93” on one side and “2263” on the other side. They are available in bottles of 100 (NDC 0093-2263-01) tablets. 875 mg : Each tablet contains 875 mg of
AMOXICILLIN, USP as the trihydrate. Each film-coated, capsule-shaped, off-white tablet is scored on one side, debossed with “93” on one side of the score and “2264” on the other side of the score. They are available in bottles of 100 (NDC 0093-2264-01) tablets.
AMOXICILLIN for oral suspension, USP : 200 mg/5 mL : Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 200 mg
AMOXICILLIN, USP as the trihydrate. It is available in bottles of 50 mL (NDC 0093-4160-76), 75 mL (NDC 0093-4160-78), and 100 mL (NDC 0093-4160-73). 250 mg/5 mL : Each 5 mL of reconstituted mixed berry flavored suspension contains 250 mg
AMOXICILLIN, USP as the trihydrate. It is available in bottles of 80 mL (NDC 0093-4155-79), 100 mL (NDC 0093-4155-73), and 150 mL (NDC 0093-4155-80). 400 mg/5 mL : Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 400 mg
AMOXICILLIN, USP as the trihydrate. It is available in bottles of 50 mL (NDC 0093-4161-76), 75 mL (NDC 0093-4161-78), and 100 mL (NDC 0093-4161-73).
AMOXICILLIN Tablets (Chewable), USP: 125 mg : Each white to off-white, capsule-shaped tablet, debossed 93 on one side and 2267 on the other side and contain 125 mg
AMOXICILLIN, USP as the trihydrate. They are available in bottles of 100 tablets (NDC 0093-2267-01). 250 mg : Each white to off-white, capsule-shaped tablet, debossed 93 (partial bisect between 9 and 3) on one side and 2268 on the other side and contain 250 mg
AMOXICILLIN, USP as the trihydrate. They are available in bottles of 100 tablets (NDC 0093-2268-01).
AMOXICILLIN capsules, USP 250 mg : Opaque caramel cap and opaque buff body, hard gelatin capsule. Printed black “TEVA” on cap and “3107” on body portions of the capsule and contain 250 mg
AMOXICILLIN, USP as the trihydrate. They are available in bottles of 100 (NDC 0093-3107-01) and 500 (NDC 0093-3107-05) capsules. 500 mg : Opaque buff cap and opaque buff body, hard gelatin capsules. Printed black “TEVA” on cap and “3109” on body portions of the capsules and contain 500 mg
AMOXICILLIN, USP as the trihydrate. They are available in bottles of 50 (NDC 0093-3109-53), 60 (NDC 0093-3109-06), 100 (NDC 0093-3109-01) and 500 (NDC 0093-3109-05) capsules. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.
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