^Overdosage
^Dosage And Administration
^Clinical Studies
^Indications And Usage
^Adverse Reactions
^Dosage Forms And Strengths
^How Supplied/storage And Handling
Amoxicillin Capsules USP are supplied as follows:
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 as the trihydrate. They are available in bottles of 100 and 500 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 as the trihydrate. They are available in bottles of 50 and 500 capsules.
Amoxicillin for Oral Suspension USP is supplied as follows:
125 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 125 mg amoxicillin as the trihydrate. It is available in bottles of 80 mL, 100 mL, and 150 mL.
250 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 250 mg amoxicillin as the trihydrate. It is available in bottles of 80 mL, 100 mL, and 150 mL.
Amoxicillin Tablets USP (Chewable) are supplied as follows:
125 mg: White to off-white, capsule-shaped tablet, debossed 93 on one side and 2267 on the other side and contain 125 mg amoxicillin as the trihydrate. They are available in bottles of 100 tablets.
250 mg: 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 as the trihydrate. They are available in bottles of 100 and 500 tablets.
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.
^Contraindications
^Warnings And Precautions
^Drug Interactions
^Clinical Pharmacology
^References
^Nonclinical Toxicology
^Information For Patients
17.1 Information for PatientsPatients should be advised that amoxicillin may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin or other antibacterial drugs in the future. Patients should be counseled that diarrhea is a common problem caused by antibiotics, and it usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible. Patients should be aware that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals.All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
Manufactured In Canada By:
TEVA CANADA LIMITED
Toronto, Canada M1B 2K9
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. W 3/2014
^Package/label Display Panel
^Use In Specific Populations