MedPath

Amoxicillin and Clavulanate Potassium

These highlights do not include all the information needed to use USP safely and effectively. See full prescribing information for . AMOXICILLIN and CLAVULANATE POTASSIUM powder for oral suspension Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, should be used only to treat infections that are proven or strongly suspected to be caused by bacteria (1).

Approved
Approval ID

9adcc6d3-28bf-32d2-e053-2995a90a24a1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 29, 2019

Manufacturers
FDA

medsource pharmaceuticals

DUNS: 833685915

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Amoxicillin and Clavulanate Potassium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code45865-928
Application NumberANDA065162
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amoxicillin and Clavulanate Potassium
Product Specifications
Route of AdministrationORAL
Effective DateDecember 29, 2019
FDA Product Classification

INGREDIENTS (10)

ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
ANHYDROUS TRISODIUM CITRATEInactive
Code: RS7A450LGA
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CLAVULANATE POTASSIUMActive
Quantity: 42.9 mg in 5 mL
Code: Q42OMW3AT8
Classification: ACTIM
AMOXICILLINActive
Quantity: 600 mg in 5 mL
Code: 804826J2HU
Classification: ACTIM

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/31/2018

2 DOSAGE AND ADMINISTRATION

Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium.. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL contains 42.9 mg of clavulanic acid per 5 mL, whereas the amoxicillin and clavulanate potassium, 200 mg/28.5 mg per 5 mL suspension contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/57 mg per 5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions should not be substituted for amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL as they are not interchangeable.

**Dosage:****Pediatric patients 3 months and older:**Based on the amoxicillin component (600 mg/5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below). This dose provides 6.4 mg/kg/day of the clavulanic acid component.

BodyWeight (kg)

Volume of Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Powder for Oral Suspension providing 90 mg/kg/day

8

3 mL twice daily

12

4.5 mL twice daily

16

6 mL twice daily

20

7.5 mL twice daily

24

9 mL twice daily

28

10.5 mL twice daily

32

12 mL twice daily

36

13.5 mL twice daily

**Pediatric patients weighing 40 kg and more:**Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in this group is not available.

**Adults:**Experience with amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL in place of the amoxicillin and clavulanate potassium 500 mg or 875 mg tablet.

Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see WARNINGS and PRECAUTIONS ( 5)].

**Directions for Mixing Oral Suspension:**Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

Amoxicillin and Clavulanate Potassium for Oral Suspension, 600 mg/42.9 mg per 5 mL Powder for Oral Suspension

Bottle Size

Amount of Water Required for Reconstitution

75 mL

68 mL

125 mL

108 mL

200 mL

170 mL

Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.

**NOTE:**SHAKE ORAL SUSPENSION WELL BEFORE USING.

**Information for the Pharmacist:**For patients who wish to alter the taste of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL, immediately after reconstitution 1 drop of FLAVORx™ (apple, banana cream, bubble gum, cherry, or watermelon flavor) may be added for every 5 mL of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. The resulting suspension is stable for 10 days under refrigeration. Stability of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL when mixed with other flavors distributed by FLAVORx has not been evaluated for flavors other than the five flavors listed above.

Administration: To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is administered at the start of a meal.

Key Highlight
  • Pediatric Patients less than 40 kg: 90 mg/kg/day divided every 12 hours, administered for 10 days. ( 2)

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Amoxicillin and Clavulanate Potassium - FDA Drug Approval Details