SUPRAX (Page 7 of 7)

17 PATIENT COUNSELING INFORMATION

17.1 Information for Patients

Patients should be counseled 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.

Phenylketonurics: Suprax (cefixime) Chewable Tablets contains 3.3 mg, 5 mg and 6.7 mg of phenylalanine per 100 mg, 150 mg and 200 mg strength, respectively.

Diarrhea is a common problem caused by antibiotics which 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 two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Products Manufactured for : Manufactured by :
Suprax® (cefixime) Tablets USP, 400 mg
Suprax® (cefixime) Capsules, 400 mg Lupin Pharma
Suprax® (cefixime) Chewable Tablets, 100 mg, 150 mg and 200 mg Baltimore, Maryland 21202 Lupin Limited
Suprax® (cefixime) for Oral Suspension USP, 200 mg/5 mL United States. Mandideep 462 046
Suprax® (cefixime) for Oral Suspension USP, 500 mg/5 mL India.
Suprax® (cefixime) for Oral Suspension USP, 100 mg/5 mL Lupin Pharmaceuticals , Inc . Baltimore, Maryland 21202United States.

Revised: March 2016 ID#: 244910

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUPRAX® CEFIXIME TABLETS USP

400 mg

Rx only

NDC 27437-201-10: Bottle of 10 Tablets

NDC 27437-201-25: Bottle of 2 Tablets [Physician Sample Pack]

NDC 27437-201-25: Carton for 2 Tablets [Physician Sample Pack]

SUPRAX CEFIXIME TABLETS USP
400 mg
Rx only
							NDC 27437-201-10 -- 10 Tablets Bottle Pack
(click image for full-size original)
SUPRAX CEFIXIME TABLETS USP
400 mg
Rx only
							NDC 27437-201-25: Bottle of 2 tablets [Physician Sample Pack]
(click image for full-size original)
SUPRAX CEFIXIME TABLETS USP
400 mg
Rx only
							NDC 27437-201-25: Carton for 2 Tablets [Physician Sample Pack]
(click image for full-size original)

SUPRAX® CEFIXIME CAPSULES

400 mg

Rx only

NDC 27437-208-08: Bottle of 50 Capsules

NDC 27437-208-11: Unit Dose Package of 10 (1 Blister of 10 Capsules)

NDC 27437-208-02: Single Dose Package of 1 (Blister of 1 Capsule)

SUPRAX CEFIXIME CAPSULES
400 mg
Rx only
							NDC 27437-208-08: Bottle of 50 capsules
(click image for full-size original)
SUPRAX CEFIXIME CAPSULES
400 mg
Rx only
							NDC 27437-208-11: Unit Dose Package of 10 (1 Blister of 10 capsules)
(click image for full-size original)
SUPRAX CEFIXIME CAPSULES
400 mg
Rx only
							NDC 27437-208-11: Unit Dose Package of 10 (1 Blister of 10 capsules)
(click image for full-size original)
SUPRAX CEFIXIME CAPSULES
400 mg
Rx only
							NDC 27437-208-02: Single Dose Package of 1 (Blister of 1 Capsule)
(click image for full-size original)
SUPRAX CEFIXIME CAPSULES
400 mg
Rx only
NDC 27437-208-08: Bottle of 50 Capsules
							NDC 27437-208-02: Single Dose Package of 1 (Blister of 1 Capsule)
(click image for full-size original)

SUPRAX® CEFIXIME CHEWABLE TABLETS

100 mg

Rx only

NDC 27437-203-10: Bottle of 10 Tablets

NDC 27437-203-11: Unit Dose Package of 10 (1 Blister of 10 Tablets)

NDC 27437-203-02: Unit Dose Package of 1 (1 Blister of 1 Tablet)

SUPRAX CEFIXIME CHEWABLE TABLETS
100 mg
Rx only
							NDC 27437-203-10: Bottle of 10 tablets
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
100 mg
Rx only
							NDC 27437-203-11: Unit Dose Package of 10 (1 blister of 10 tablets)
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
100 mg
Rx only
							NDC 27437-203-11: Unit Dose Package of 10 (1 blister of 10 tablets)
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
100 mg
Rx only
							NDC 27437-203-02: Unit Dose Package of 1 (1 Blister of 1 Tablet)
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
100 mg
Rx only
							NDC 27437-203-02: Unit Dose Package of 1 (1 Blister of 1 Tablet)
(click image for full-size original)

SUPRAX® CEFIXIME CHEWABLE TABLETS

150 mg

Rx only

NDC 27437-204-10: Bottle of 10 Tablets

NDC 27437-204-11: Unit Dose Package of 10 (1 Blister of 10 Tablets)

SUPRAX CEFIXIME CHEWABLE TABLETS
150 mg
Rx only
							NDC 27437-204-10: Bottle of 10 tablets
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
150 mg
Rx only
							NDC 27437-204-11: Unit Dose Package of 10 (1 blister of 10 tablets)
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
150 mg
Rx only
							NDC 27437-204-11: Unit Dose Package of 10 (1 blister of 10 tablets)
(click image for full-size original)

SUPRAX® CEFIXIME CHEWABLE TABLETS

200 mg

Rx only

NDC 27437-205-10: Bottle of 10 Tablets

NDC 27437-205-11: Unit Dose Package of 10 (1 Blister of 10 Tablets)

NDC 27437-205-02: Single Dose Package (Blister of 1 Tablet)

SUPRAX CEFIXIME CHEWABLE TABLETS
200 mg
Rx only
							NDC 27437-205-10: Bottle of 10 tablets
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
200 mg
Rx only
							NDC 27437-205-11: Unit Dose Package of 10 (1 blister of 10 tablets)
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
200 mg
Rx only
							NDC 27437-205-11: Unit Dose Package of 10 (1 blister of 10 tablets)
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
200 mg
Rx only
							NDC 27437-205-02: Single Dose Package (Blister of 1 Tablet)
(click image for full-size original)
SUPRAX CEFIXIME CHEWABLE TABLETS
200 mg
Rx only
							NDC 27437-205-02: Single Dose Package (Blister of 1 Tablet)
(click image for full-size original)

SUPRAX® CEFIXIME FOR ORAL SUSPENSION USP

200 mg/5 mL

Rx only

NDC 27437-206-05: Bottle of 25 mL

NDC 27437-206-04: Bottle of 10 mL [Physician Sample Pack]

NDC 27437-206-04: Carton for 10 mL [Physician Sample Pack]

SUPRAX CEFIXIME FOR ORAL SUSPENSION USP
200 mg/5 mL
Rx only
							NDC 27437-206-05: Bottle of 25 mL
(click image for full-size original)
SUPRAX CEFIXIME FOR ORAL SUSPENSION USP
200 mg/5 mL
Rx only
							NDC 27437-206-04: Bottle of 10 mL [Physician Sample Pack]
(click image for full-size original)
SUPRAX CEFIXIME FOR ORAL SUSPENSION USP
200 mg/5 mL
Rx only
							NDC 27437-206-04: Carton for 10 mL [Physician Sample Pack]
(click image for full-size original)

SUPRAX® CEFIXIME FOR ORAL SUSPENSION USP

500 mg/5 mL

Rx only

NDC 27437-207-02: Bottle of 10 mL

NDC 27437-207-02: Carton for 10 mL

NDC 27437-207-04: Bottle of 10 mL [Physician Sample Pack]

NDC 27437-207-04: Carton for 10 mL [Physician Sample Pack]

SUPRAX CEFIXIME FOR ORAL SUSPENSION USP
500 mg/5 mL
Rx only
							NDC 27437-207-02: Bottle of 10 mL
(click image for full-size original)
SUPRAX CEFIXIME FOR ORAL SUSPENSION USP
500 mg/5 mL
Rx only
							NDC 27437-207-02: Bottle of 10 mL
(click image for full-size original)
SUPRAX CEFIXIME FOR ORAL SUSPENSION USP
500 mg/5 mL
Rx only
							NDC 27437-207-04: Bottle of 10 mL [Physician Sample Pack]
(click image for full-size original)
SUPRAX CEFIXIME FOR ORAL SUSPENSION USP
500 mg/5 mL
Rx only
							NDC 27437-207-04: Carton for 10 mL [Physician Sample Pack]
(click image for full-size original)
SUPRAX cefixime tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-201
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 400 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOLS
STARCH, PREGELATINIZED CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (White to off white) Score 2 pieces
Shape CAPSULE (Capsule shaped tablets with beveled edges) Size 19mm
Flavor Imprint Code SUPRAX;LUPIN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-201-01 100 TABLET in 1 BOTTLE None
2 NDC:57297-201-08 50 TABLET in 1 BOTTLE None
3 NDC:57297-201-10 10 TABLET in 1 BOTTLE None
4 NDC:57297-201-25 1 BOTTLE in 1 CARTON contains a BOTTLE
4 2 TABLET in 1 BOTTLE This package is contained within the CARTON (57297-201-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065130 04/01/2008
SUPRAX cefixime capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-208
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 400 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
GELATIN
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
MANNITOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
Product Characteristics
Color PINK (Pink Opaque Cap) , PINK (Pink Opaque Body) Score no score
Shape CAPSULE Size 26mm
Flavor Imprint Code LU;U43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-208-08 50 CAPSULE in 1 BOTTLE None
2 NDC:57297-208-11 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (57297-208-11)
3 NDC:57297-208-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (57297-208-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA203195 03/15/2013
SUPRAX cefixime tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-203
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
ASPARTAME
CROSPOVIDONE
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color PINK (Pink) Score no score
Shape ROUND (Round) Size 11mm
Flavor TUTTI FRUTTI Imprint Code SUPRAX100;LUPIN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-203-10 10 TABLET, CHEWABLE in 1 BOTTLE None
2 NDC:57297-203-08 50 TABLET, CHEWABLE in 1 BOTTLE None
3 NDC:57297-203-11 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (57297-203-11)
4 NDC:57297-203-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (57297-203-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065380 12/05/2012
SUPRAX cefixime tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-205
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 200 mg
Inactive Ingredients
Ingredient Name Strength
ALUMINUM OXIDE
ASPARTAME
CROSPOVIDONE
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
MAGNESIUM STEARATE
MANNITOL
SILICON DIOXIDE
Product Characteristics
Color PINK (Pink) Score no score
Shape ROUND (Round) Size 14mm
Flavor Imprint Code SUPRAX200;LUPIN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-205-10 10 TABLET, CHEWABLE in 1 BOTTLE None
2 NDC:57297-205-08 50 TABLET, CHEWABLE in 1 BOTTLE None
3 NDC:57297-205-11 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 10 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (57297-205-11)
4 NDC:57297-205-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 1 TABLET, CHEWABLE in 1 BLISTER PACK This package is contained within the CARTON (57297-205-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065380 12/05/2012
SUPRAX cefixime powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-206
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 200 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 Powder) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-206-01 100 mL in 1 BOTTLE None
2 NDC:57297-206-02 75 mL in 1 BOTTLE None
3 NDC:57297-206-03 50 mL in 1 BOTTLE None
4 NDC:57297-206-06 37.5 mL in 1 BOTTLE None
5 NDC:57297-206-05 25 mL in 1 BOTTLE None
6 NDC:57297-206-04 1 BOTTLE in 1 CARTON contains a BOTTLE
6 10 mL in 1 BOTTLE This package is contained within the CARTON (57297-206-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065355 06/01/2007
SUPRAX cefixime powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-207
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFIXIME (CEFIXIME ANHYDROUS) CEFIXIME ANHYDROUS 500 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
SODIUM BENZOATE
STRAWBERRY
SUCRALOSE
SUCROSE
XANTHAN GUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-207-02 10 mL in 1 BOTTLE None
2 NDC:57297-207-03 20 mL in 1 BOTTLE None
3 NDC:57297-207-04 1 BOTTLE in 1 CARTON contains a BOTTLE
3 10 mL in 1 BOTTLE This package is contained within the CARTON (57297-207-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202091 03/15/2013
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 725504448 manufacture (57297-201), manufacture (57297-203), manufacture (57297-205), manufacture (57297-206), manufacture (57297-207), manufacture (57297-208)

Revised: 03/2016 LUPIN LIMITED

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.