Drug Safety Labeling Changes - March 2011

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March 2011

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Fareston (toremifene citrate) tabletsBoxed WarningContraindicationsWarningsPrecautions----
Strattera (atomoxetine hydrochloride) capsules-Contraindications------
Advil Cold & Sinus Liqui-Gels (ibuprofen 200 mg and pseudoephedrine HCl 30 mg) capsules (OTC)--Warnings-----
Azasite (azithromycin) ophthalmic solution--WarningsPrecautionsAdverse Reactions---
Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) tablets--WarningsPrecautions----
Etopophos (etoposide phosphate) powder for injection--Warnings-----
Inderal (propranolol HCL) tabletsInderal LA (propranolol hydrochloride) long acting capsules--Warnings-----
Inderide (propranolol hydrochloride/hydrochlorothiazide) tablets--Warnings-----
Integrilin (eptifibatide) injection--Warnings-Adverse Reactions---
Lopressor HCT (metoprolol tartrate/hydrochlorothiazide) tablets--Warnings-----
Drug Name BW C W P AR PPI MG PCI
PhosLo (calcium acetate) 667 mg gelcaps--WarningsPrecautionsAdverse Reactions---
Sectral (acebutolol hydrochloride) tablets--Warnings-----
Talacen (pentazocine hydrochloride and acetaminophen) tablets--WarningsPrecautionsAdverse Reactions---
Yaz (drospirenone/ethinyl estradiol) tablets--WarningsPrecautions----
Bicnu (carmustine) for injection---PrecautionsAdverse Reactions---
Humulin R (insulin human [rDNA origin] injection), U-500---Precautions----
Kerledex (betaxolol hydrochloride and chlorthalidone)---Precautions----
PAH (aminohippurate sodium injection) vials---Precautions----
Trileptal (oxcarbazepine) tablets and suspension---PrecautionsAdverse Reactions---
AccuNeb (albuterol sulfate) inhalation solution----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Flolan (epoprostenol sodium) injection----Adverse Reactions---
Lexapro (escitalopram oxalate) tablets and oral solution----Adverse Reactions---
Neurontin (gabapentin) capsules, tablets, and oral solution----Adverse Reactions---
Veletri (epoprostenol sodium) injection----Adverse Reactions---
Xyzal (levocetirizine dihydrochloride) oral solution and tablets----Adverse Reactions---
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