NDC Code(s) : 0173-0740-00, 0173-0387-00, 0173-0741-00, 0173-0741-10
Packager : GlaxoSmithKline LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CEFTINcefuroxime axetil POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0740
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL(UNII: Z49QDT0J8Z)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
ASPARTAME(UNII: Z0H242BBR1)
POVIDONE K30(UNII: U725QWY32X)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor TUTTI FRUTTI Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0173-0740-00100 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product06/02/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050672 06/02/2004 09/30/2018
CEFTINcefuroxime axetil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0387
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL(UNII: Z49QDT0J8Z)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSES(UNII: 3NXW29V3WO)
METHYLPARABEN(UNII: A2I8C7HI9T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE Score no score
Shape OVAL (capsule shaped) Size 15 mm
Flavor Imprint Code GX;ES7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0173-0387-0020 in 1 BOTTLE Type 0: Not a Combination Product10/01/1989
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050605 10/01/1989 04/30/2018
CEFTINcefuroxime axetil POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0173-0741
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFUROXIME AXETIL(UNII: Z49QDT0J8Z)
(CEFUROXIME - UNII:O1R9FJ93ED) 		CEFUROXIME250 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
ASPARTAME(UNII: Z0H242BBR1)
POVIDONE K30(UNII: U725QWY32X)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCROSE(UNII: C151H8M554)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor TUTTI FRUTTI Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0173-0741-00100 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product06/02/2004
2NDC:0173-0741-1050 mL in 1 BOTTLE, GLASS Type 0: Not a Combination Product06/02/2004
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050672 06/02/2004 09/30/2018

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0173-0387-00

Ceftin® Tablets

(cefuroxime axetil tablets)

250 mg

20 tablets

Rx only

Replace cap securely after each opening.

Each tablet contains cefuroxime axetil equivalent to 250 mg of cefuroxime.

See package insert for Dosage and Administration.

Store between 15º and 30ºC (59º and 86ºF).

GlaxoSmithKline

RTP, NC 27709

Made in England

  •  10000000136237 Rev. 9/15
ceftin 250 mg 20 count label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0173-0740-00

Ceftin® for Oral Suspension

(cefuroxime axetil for oral suspension)

For Oral Use Only

125 mg per 5 mL

100 mL (when reconstituted)

Rx only

Contains 3.0 g of cefuroxime axetil equivalent to 2.5 g of cefuroxime.

Phenylketonurics: Contains Phenylalanine 11.8 mg per 5 mL (1 teaspoonful) constituted suspension.

See package insert for Dosage and Administration.

Directions for Mixing Oral Suspension: Prepare the suspension at time of dispensing. Shake the bottle to loosen the powder. Remove the cap. Add 37 mL of water for reconstitution and replace the cap. Invert bottle and vigorously rock it from side to side so that water rises through the powder. Once the sound of powder against the bottle disappears, turn thebottle upright and vigorously shake it in a diagonal direction.

Before reconstitution, store dry powder between 2º and 30ºC (36º and 86ºF).

After reconstitution, store suspension between 2º and 8ºC (36º and 46ºF), in a refrigerator. SHAKE WELL BEFORE EACH USE. Replace cap securely after each opening. Discard after 10 days.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in England

  •  10000000136641 Rev. 8/15
ceftin oral suspension 125 mg per 5 ml, 100 ml bottle label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0173-0741-10

Ceftin® for Oral Suspension

(cefuroxime axetil for oral suspension)

For Oral Use Only

250 mg per 5 mL

50 mL (when reconstituted)

Rx only

Contains 3.6 g of cefuroxime axetil equivalent to 3 g of cefuroxime.

Phenylketonurics: Contains Phenylalanine 25.2 mg per 5 mL (1 teaspoonful) constituted suspension.

See package insert for Dosage and Administration.

Directions for Mixing Oral Suspension: Prepare the suspension at time of dispensing. Shake the bottle to loosen the powder. Remove the cap. Add 19 mL of water for reconstitution and replace the cap. Invert bottle and vigorously rock it from side to side so that water rises through the powder. Once the sound of powder against the bottle disappears, turn the bottle upright and vigorously shake it in a diagonal direction.

Before reconstitution, store dry powder between 2º and 30ºC (36º and 86ºF).

After reconstitution, store suspension between 2º and 8ºC (36º and 46ºF), in a refrigerator. SHAKE WELL BEFORE EACH USE. Replace cap securely after each opening. Discard after 10 days.

GlaxoSmithKline

RTP, NC 27709

Made in England

  •  10000000136681 Rev. 8/15
ceftin oral suspension 250 mg per 5 mL, 50 mL bottle label