Cefuroxime axetil labels and packages

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Cefuroxime axetil
CEFTIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
Clinical Studies
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

Principal Display Panel

NDC 0173-0387-00

Ceftin® Tablets

(cefuroximeaxetil tablets)

250 mg 20 Tablets

Rx only

See package insert for Dosage and Administration.

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

Replace cap securely after each opening.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in England

4142817

Rev. 2/02

Principal Display Panel

NDC 0173-0394-00

Ceftin® Tablets

(cefuroximeaxetil tablets)

500 mg

Rx only

20 Tablets

Each tablet contains cefuroxime axetil equivalent to 500 mg of cefuroxime.

See package insert for Dosage and Administration.

Store between 15o and 30oC (59o and 86oF). Replace cap securely after each opening.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in England

4141667 Rev. 12/01

Principal Display Panel

NDC 0173-0740-00

Ceftin® for Oral Suspension

(cefuroximeaxetil powder for oral suspension)

For Oral Use Only

125 mg per 5 mL

100 mL (when reconstituted)

Rx only

Contains 3.0 g 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 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

Research Triangle Park, NC 27709

Made in England

10000000022540 Rev. 12/05

Principal Display Panel

NDC 0173-0741-10

Ceftin® for Oral Suspension

(cefuroximeaxetil powder for oral suspension)

For Oral Use Only

250 mg per 5 mL

50 mL (when reconstituted)

Contains 3.6 g 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

Research Triangle Park, NC 27709

Made in England

10000000022489 Rev. 12/05



References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050605s042lbl.pdf