TOPROL XL (Page 6 of 6)

17 PATIENT COUNSELING INFORMATION

Advise patients to take TOPROL-XL regularly and continuously, as directed, preferably with or immediately following meals. If a dose is missed, the patient should take only the next scheduled dose (without doubling it). Patients should not interrupt or discontinue TOPROL-XL without consulting the physician.

Advise patients (1) to avoid operating automobiles and machinery or engaging in other tasks requiring alertness until the patient’s response to therapy with TOPROL-XL has been determined; (2) to contact the physician if any difficulty in breathing occurs; (3) to inform the physician or dentist before any type of surgery that he or she is taking TOPROL-XL.

Heart failure patients should be advised to consult their physician if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath.

TOPROL-XL and PLENDIL are trademarks of the AstraZeneca group of companies.

© AstraZeneca 2012, 2013, 2014

Distributed by: AstraZeneca LP

Wilmington, DE 19850

Repackaged by:

Cardinal Health

Zanesville, OH 43701

L35044871211

L34323661111

L35044950216

Rev. 35556-04

Package/Label Display Panel

Toprol-XL® 25 mg*

Metoprolol Succinate

Extended-release tablets

10 tablets

bag label
(click image for full-size original)

Package/Label Display Panel

Toprol-XL® 50 mg*

Metoprolol Succinate

Extended-release tablets

10 tablets

bag label
(click image for full-size original)

Package/Label Display Panel

Toprol-XL® 100 mg*

Metoprolol Succinate

Extended-release tablets

10 tablets

bag label
(click image for full-size original)
TOPROL XL
metoprolol succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-9608(NDC:0186-1088)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
AMMONIUM LAURETH-5 SULFATE
TITANIUM DIOXIDE
PARAFFIN
WATER
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ACETYLTRIBUTYL CITRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL (biconvex) Size 10mm
Flavor Imprint Code AB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-9608-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BAG (55154-9608-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019962 05/10/2010 08/31/2015
TOPROL XL
metoprolol succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5026(NDC:0186-1090)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
AMMONIUM LAURETH-5 SULFATE
TITANIUM DIOXIDE
PARAFFIN
WATER
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ACETYLTRIBUTYL CITRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (biconvex) Size 9mm
Flavor Imprint Code A;mo
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-5026-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BAG (55154-5026-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019962 05/10/2010 09/30/2015
TOPROL XL
metoprolol succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-9609(NDC:0186-1092)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METOPROLOL SUCCINATE (METOPROLOL) METOPROLOL TARTRATE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
AMMONIUM LAURETH-5 SULFATE
TITANIUM DIOXIDE
PARAFFIN
WATER
ETHYLCELLULOSE, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
ACETYLTRIBUTYL CITRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
LACTOSE, UNSPECIFIED FORM
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (biconvex) Size 10mm
Flavor Imprint Code A;ms
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-9609-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BAG (55154-9609-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019962 05/10/2010 10/31/2019
Labeler — Cardinal Health (188557102)
Registrant — AstraZeneca PLC (230790719)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK (55154-9608), REPACK (55154-5026), REPACK (55154-9609)

Revised: 03/2018 Cardinal Health

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 © 2019. All Rights Reserved.