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Metoprolol Succinate (Page 6 of 6)

15 REFERENCES:

1. Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008; 371:1839-47.

16. HOW SUPPLIED/STORAGE AND HANDLING

Metoprolol succinate extended-release tablets USP, 100 mg are white to off-white, round shaped, film-coated tablets, debossed with “M” and “3” separated by breakline on one side and plain on other side. They are supplied in unit dose packages of 100 (10 x 10) NDC 68084-673-01

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature.]

17. PATIENT COUNSELING INFORMATION

Advise patients to take metoprolol succinate extended-release tablets 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 metoprolol succinate extended-release tablets 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 metoprolol succinate extended-release tablets 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 metoprolol succinate extended-release tablets.

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.

PLENDIL is a trademark of the AstraZeneca group of companies.

Rx Only

PACKAGING INFORMATION

American Health Packaging unit dose blisters (see How Supplied section) contain drug product from BluePoint Laboratories as follows:
(100 mg / 100 UD) NDC 68084-673-01 packaged from NDC 68001-119

Packaged and Distributed by:
American Health Packaging Columbus, OH 43217

8267301/0914

PRINCIPAL DISPLAY PANEL

Metoprolol succinate 100 mg Label
(click image for full-size original)

NDC 68084-673-01

Metoprolol Succinate
Extended-Release
Tablets, USP

100 mg*

100 Tablets (10 × 10)

* Each film-coated tablet contains 95 mg
metoprolol succinate equivalent to 100 mg
metoprolol tartrate, USP.

USUAL DOSAGE: See package insert.

Store at 20º to 25ºC (68º to 77ºF)
[See USP Controlled Room Temperature].

Keep this and all drugs out of reach of children.

Rx Only

The drug product contained in this package is
from NDC # 68001-119, BluePoint Laboratories.

Packaged and Distributed by:
American Health Packaging
Columbus, Ohio 43217

067301Rev. 08/2014

METOPROLOL SUCCINATE metoprolol succinate tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68084-673(NDC:68001-119)
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
ACETYLTRIBUTYL CITRATE
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
ETHYLCELLULOSES
HYDROGENATED COTTONSEED OIL
HYDROXYPROPYL CELLULOSE (TYPE H)
HYPROMELLOSES
METHYLENE CHLORIDE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
SODIUM STEARYL FUMARATE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code M;3
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68084-673-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK (68084-673-11)
1 NDC:68084-673-11 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (68084-673-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078889 05/12/2014
Labeler — American Health Packaging (007914906)
Establishment
Name Address ID/FEI Operations
American Health Packaging 929561009 REPACK (68084-673)

Revised: 12/2014 American Health Packaging

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