Amoxicillin (Page 6 of 6)

17 PATIENT COUNSELING INFORMATION

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17.1 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.

CLINITEST® is a registered trademark of Siemens Medical Solutions Diagnostics, and Ames Company, Inc.
CLINISTIX® is a registered trademark of Bayer Healthcare Llc, and Ames Company, Inc.
CLOtest® is a registered trademark of Kimberly-Clark Worldwide, Inc.
Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India
Revised: 03/2013

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 875 mg (100 Tablet Bottle)


NDC 65862-015-01
Amoxicillin Tablets, USP
875 mg
Rx only 100 Tablets

AUROBINDO

Amoxicillin 875mg Tablets #20
(click image for full-size original)
AMOXICILLIN amoxicillin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66116-477(NDC:65862-015)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 875 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
D&C RED NO. 30
HYPROMELLOSE 2910 (6 MPA.S)
HYPROMELLOSE 2910 (15 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 3350
POLYETHYLENE GLYCOL 8000
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL (CAPSULE-SHAPED) Size 21mm
Flavor Imprint Code A;6;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66116-477-20 20 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065256 11/09/2005
Labeler — MedVantx, Inc. (806427725)
Registrant — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 REPACK (66116-477)

Revised: 03/2013 MedVantx, Inc.

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