Amoxicillin (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

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 150 mL (NDC 53217-0312-01).

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 100 mL (NDC 53217-0314-01).

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.

Repackaged by:

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

17 PATIENT COUNSELING INFORMATION

Information for Patients

  • •Patients 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, INC.

North Wales, PA 19454

  • Rev. Y 12/2015

Package/Label Display Panel

Amoxicillin 125mg-5ml Susp. 150ml
(click image for full-size original)

Amoxicillin 125mg-5ml Susp. 150ml

Amoxicillin for Oral Suspension USP 125 mg per 5 mL 100 mL Label Text

NDC 0093-4150- 73

Amoxicillin
for Oral Suspension USP
equivalent to
125 mg per 5 mL
amoxicillin when reconstituted

according to directions.

See accompanying literature.

WARNING: NOT FOR INJECTION

Rx only

100 mL (when mixed)

TEVA

Package/Label Display Panel

Amoxicillin 250mg-5ml Susp. 100ml
(click image for full-size original)

Amoxicillin 250mg-5ml Susp. 100ml

Amoxicillin for Oral Suspension USP 250 mg per 5 mL 100 mL Label Text

NDC 0093-4155- 73

Amoxicillin
for Oral Suspension USP
equivalent to
250 mg per 5 mL

amoxicillin when reconstituted
according to directions.

See accompanying literature.

WARNING: NOT FOR INJECTION

Rx only

100 mL (when mixed)

TEVA

AMOXICILLIN
amoxicillin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-312(NDC:0093-4150)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM CITRATE
SUCROSE
XANTHAN GUM
Product Characteristics
Color PINK Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-312-01 150 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061931 09/30/1990
AMOXICILLIN
amoxicillin powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-314(NDC:0093-4155)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
FD&C RED NO. 40
SILICON DIOXIDE
SODIUM BENZOATE
SODIUM CITRATE
SUCROSE
XANTHAN GUM
Product Characteristics
Color PINK Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-314-01 100 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA061931 09/30/1990
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 05/2017 Aidarex Pharmaceuticals LLC

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