AMOXICILLIN AND CLAVULANATE POTASSIUM (Page 6 of 6)

15 REFERENCES


1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.

16 HOW SUPPLIED/STORAGE AND HANDLING

Amoxicillin and Clavulanate Potassium Tablets USP are supplied as follows:

Amoxicillin and clavulanate potassium tablets USP, 250 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets, debossed with “I 05” on one side and plain on the other side. Each tablet contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows.

Bottles of 30 NDC 42571-160-30

Bottles of 100 NDC 42571-160-01

Carton of 100 (10×10 Unit-dose) NDC 42571-160-11

Amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 06” on one side and plain on the other side. Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows.

Bottles of 20 NDC 42571-161-42

Bottles of 100 NDC 42571-161-01

Carton of 100 (10×10 Unit-dose) NDC 42571-161-11

Amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 07” on one side score line on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows.

Bottles of 20 NDC 42571-162-42

Bottles of 100 NDC 42571-162-01

Carton of 40 (4×10 Unit-dose) NDC 42571-162-44

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

Patients should be informed that amoxicillin and clavulanate potassium tablets may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset.

Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium tablets are 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 and clavulanate potassium tablets or other antibacterial drugs in the future.

Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, 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 antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician.

Patients should be advised to keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium, use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use. Bottles of suspension of amoxicillin and clavulanate potassium may contain more liquid than required. Follow your doctor’s instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.

Patients should be aware that amoxicillin and clavulanate potassium tablets contain 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 Micro Labs Limited.

Manufactured by:

Micro Labs Limited

Banglore-560 100, India.

Manufactured for:

Micro Labs USA Inc.

Basking Ridge, NJ 07920

Revised: July 2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42571-160-30
Amoxicillin and Clavulanate
Potassium Tablets, USP
250 mg/125 mg*
Rx Only
30 Tablets MICRO LABS

250 mg/125 mg label
(click image for full-size original)

NDC 42571-160-11
Amoxicillin and Clavulante
Potassium Tablets, USP
250 mg/125 mg*
Rx Only
100 Tablets (10×10 Unit-dose) MICRO LABS

250 mg/125 mg carton label
(click image for full-size original)

NDC 42571-161-42
Amoxicillin and Clavulante
Potassium Tablets, USP
500 mg/125 mg*
Rx Only
20 Tablets MICRO LABS

500 mg/125 mg label
(click image for full-size original)

NDC 42571-161-11
Amoxicillin and Clavulante
Potassium Tablets, USP
500 mg/125 mg*
Rx Only 100 Tablets (10×10 Unit-dose)

500 mg/125 mg carton label
(click image for full-size original)

NDC 42571-162-42
Amoxicillin and Clavulanate
Potassium Tablets, USP
875 mg/125 mg*
Rx Only
20 Tablets MICRO LABS LIMITED

875 mg/125 mg label
(click image for full-size original)

NDC 42571-162-44
Amoxicillin and Clavulanate
Potassium Tablets, USP
875 mg/125 mg*
Rx Only
40 Tablets (4 x 10 Unit-dose) MICRO LABS LIMITED

875 mg/125 mg carton label
(click image for full-size original)
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 250 mg
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
ETHYLCELLULOSE (10 MPA.S)
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE (biconvex) Size 17mm
Flavor Imprint Code I05
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-160-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42571-160-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:42571-160-11 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-160-32)
3 NDC:42571-160-32 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42571-160-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205707 03/01/2017
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-161
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 500 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
ETHYLCELLULOSE (10 MPA.S)
TALC
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE (biconvex) Size 19mm
Flavor Imprint Code I06
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-161-42 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42571-161-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:42571-161-11 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-161-32)
3 NDC:42571-161-32 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42571-161-11)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205707 03/01/2017
AMOXICILLIN AND CLAVULANATE POTASSIUM amoxicillin and clavulanate potassium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMOXICILLIN (AMOXICILLIN ANHYDROUS) AMOXICILLIN ANHYDROUS 875 mg
CLAVULANATE POTASSIUM (CLAVULANIC ACID) CLAVULANIC ACID 125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYPROMELLOSE 2910 (5 MPA.S)
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
ETHYLCELLULOSE (10 MPA.S)
TALC
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape CAPSULE (biconvex) Size 22mm
Flavor Imprint Code I07
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-162-42 20 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42571-162-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:42571-162-44 4 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-162-43)
3 NDC:42571-162-43 4 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (42571-162-44)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204755 03/01/2017
Labeler — Micro Labs Limited (862174955)
Establishment
Name Address ID/FEI Operations
Micro Labs Limited 867064609 analysis (42571-160), analysis (42571-161), analysis (42571-162), label (42571-160), label (42571-161), label (42571-162), manufacture (42571-160), manufacture (42571-161), manufacture (42571-162), pack (42571-160), pack (42571-161), pack (42571-162)

Revised: 07/2020 Micro Labs Limited

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