SUPRAX (Page 7 of 7)

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

Counsel patients that antibacterial drugs, including cefixime, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When cefixime 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 cefixime for oral suspension or cefixime chewable tablets or other antibacterial drugs in the future.

Counsel patients with phenylketonuria that SUPRAX chewable tablets contain aspartame, a source of phenylalanine as follows: Each SUPRAX chewable tablet contains 3.3 mg, 5 mg and 6.7 mg of phenylalanine per 100 mg, 150 mg and 200 mg strength, respectively.

Advise patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.

Products	Manufactured for:	Manufactured by:
SUPRAX ® (cefixime) tablets, 400 mg
SUPRAX ® (cefixime) capsules, 400 mg
SUPRAX ® (cefixime) chewable tablets, 100 mg, 150 mg and 200 mg	Lupin Pharma Baltimore, Maryland 21202 United States.
SUPRAX ® (cefixime) for oral suspension, 200 mg/5 mL		Lupin Limited Mandideep 462 046 India.
SUPRAX ® (cefixime) for oral suspension, 500 mg/5 mL
SUPRAX ® (cefixime) for oral suspension, 100 mg/5 mL	Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States

ID#: 254614

SUPRAX^® CEFIXIME FOR ORAL SUSPENSION USP

100 mg/5 mL

Rx only

NDC 68180-202-03: Bottle of 50 mL

SUPRAX^® CEFIXIME FOR ORAL SUSPENSION USP

100 mg/5 mL

Rx only

NDC 68180-202-04: Bottle of 10 mL (Physician Sample Pack)

NDC 68180-202-05: Carton for 10 mL x 6 Bottles (Physician Sample Pack)

SUPRAX cefixime powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-202 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 100 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE SODIUM BENZOATE STRAWBERRY SUCROSE XANTHAN GUM

Product Characteristics Color WHITE (off-white to pale yellow) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68180-202-05 6 BOTTLE in 1 CARTON contains a BOTTLE (68180-202-04) 1 NDC:68180-202-04 10 mL in 1 BOTTLE This package is contained within the CARTON (68180-202-05) 2 NDC:68180-202-03 50 mL in 1 BOTTLE None 3 NDC:68180-202-02 75 mL in 1 BOTTLE None 4 NDC:68180-202-01 100 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA065129 03/01/2004

Labeler — Lupin Pharmaceuticals, Inc. (089153071)

Registrant — LUPIN LIMITED (675923163)

Establishment
Name	Address	ID/FEI	Operations
LUPIN LIMITED		725504448	MANUFACTURE (68180-202)

Revised: 01/2020 Lupin Pharmaceuticals, Inc.