NDC 50107-200 - Reme-Flu

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50107-200
Package NDCs from labels
50107-200-00
Manufacturer
Legacy Biotechnologies Inc. | Washington Homeopathic Products
Effective date
2009-12-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Reme-Flu - Legacy Biotechnologies Inc. | Washington Homeopathic ProductsLegacy Biotechnologies Inc. | Washington Homeopathic Products2009-12-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50107-200-00Reme-Flu12 in 1 BOTTLE, DROPPERLIQUID123 [hp_X]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50107-200REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1Unmatched20091224_705f016c-4bdc-4a5c-8b38-324eee861cf2.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARSENICACTIVE INGREDIENTN712M78A8GREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2BREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
ERIODICTYONACTIVE INGREDIENT2Y7TIQ135HREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
EUCALYPTUS GLOBULUS LEAFACTIVE INGREDIENTS546YLW6E6REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6EREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1QREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
INULAACTIVE INGREDIENTE55SMD6DA8REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
MAGNESIUM PHOSPHATEACTIVE INGREDIENT453COF7817REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
SAMBUCUS NIGRA FLOWERACTIVE INGREDIENT07V4DX094TREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
TRIBASIC CALCIUM PHOSPHATEACTIVE INGREDIENT91D9GV0Z28REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
ARSENICACTIVE MOIETYN712M78A8GREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2BREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZBREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
ERIODICTYONACTIVE MOIETY2Y7TIQ135HREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
EUCALYPTUS GLOBULUS LEAFACTIVE MOIETYS546YLW6E6REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6EREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1QREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
INULAACTIVE MOIETYE55SMD6DA8REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY838REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
POTASSIUM CATIONACTIVE MOIETY295O53K152REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
SAMBUCUS NIGRA FLOWERACTIVE MOIETY07V4DX094TREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554REME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREME-FLU (BRYONIA ALBA ROOT,EUPATORIUM PERFOLIATUM FLOWERING TOP,GELSEMIUM SEMPERVIRENS ROOT, ARSENIC, ERIODICTYON, EUCALYPTUS GLOBULUS LEAF , INULA, SAMBUCUS NIGRA FLOWER, POTASSIUM CHLORIDE, SODIUM CHLORIDE , MAGNESIUM PHOSPHATE , TRIBASIC CALCIUM PHOSPHATE ) KIT [LEGACY BIOTECHNOLOGIES INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 79 of 258 · 5,143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neuro Relax Drops 2055NEURO RELAX DROPSProfessional Complementary Health Formulas50cf1c24-4ae9-42e8-a2a3-4d83cc5bfb5a2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: 451W47IQ8X
Opsin II 6015OPSIN IIProfessional Complementary Health Formulas848d620e-ddd5-4787-a4bd-844be76154322026-01-08WarningsExact identifier
unii: 451W47IQ8X
Pain Formula IV Drops 2092PAIN FORMULA IV DROPSProfessional Complementary Health Formulas41e0eb72-7474-4d95-b316-6ffec7ffbfcd2026-01-08WarningsExact identifier
unii: T7J046YI2B
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Rheuma Pain Drops 2057RHEUMA PAIN DROPSProfessional Complementary Health Formulasb28afc03-b0c7-41cf-86bf-c89d9af514d42026-01-08WarningsExact identifier
unii: T7J046YI2B
Aconitum Combination 9201ACONITUM COMBINATIONProfessional Complementary Health Formulasa9704081-067e-48dd-bcfd-02eddb1cf2792026-01-08WarningsExact identifier
unii: S546YLW6E6
Mucolytic Drainage Liquescence 3017MUCOLYTIC DRAINAGE LIQUESCENCEProfessional Complementary Health Formulasf6dd9b87-053d-4d88-b0e4-7693f5524ce72026-01-08WarningsExact identifier
unii: E55SMD6DA8
unii: S546YLW6E6
Pain Formula I Drops 2089PAIN FORMULA I DROPSProfessional Complementary Health Formulasfe6aeed7-95de-4ca0-828e-61451b467c722026-01-08WarningsExact identifier
unii: T7J046YI2B
Migraine Drops 2140MIGRAINE DROPSProfessional Complementary Health Formulascdae292a-b331-491d-bb4c-73fc15bfc8642026-01-08WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Northwest Regional 1019NORTHWEST REGIONALProfessional Complementary Health Formulas4dccc9f6-4d9e-4eec-b031-1fccdddb3d032026-01-08WarningsExact identifier
unii: 451W47IQ8X
Organic Acid Combination 9305ORGANIC ACID COMBINATIONProfessional Complementary Health Formulasf2e752c9-2cf1-4511-bf07-5cf422af759c2026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Glyoxal Combination 9303GLYOXAL COMBINATIONProfessional Complementary Health Formulasb392b61f-9bfb-4296-b99d-41f1101d26e52026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Headache Drops 2027HEADACHE DROPSProfessional Complementary Health Formulasa7e345fb-c4aa-4b10-8074-9d8c373041422026-01-08WarningsExact identifier
unii: 639KR60Q1Q
unii: 451W47IQ8X
Turskas Liquescence 3008TURSKAS LIQUESCENCEProfessional Complementary Health Formulasac81152a-6f06-48f8-bf2c-e446c70e0ef52026-01-08WarningsExact identifier
unii: 639KR60Q1Q
unii: T7J046YI2B
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: 451W47IQ8X
Connective Tissue Liquescence 3024CONNECTIVE TISSUE LIQUESCENCEProfessional Complementary Health Formulasb7dab801-0256-40d7-8f66-7a0e7e76c3532026-01-08WarningsExact identifier
unii: T7J046YI2B
unii: 1W0775VX6E
Glycerin Combination 9304GLYCERIN COMBINATIONProfessional Complementary Health Formulas391d8517-9b89-4b62-97b5-5102b35bec462026-01-08WarningsExact identifier
unii: 639KR60Q1Q
Pleurisy Drops 2047PLEURISY DROPSProfessional Complementary Health Formulasb046d33f-170b-4b59-aa58-7632db9694fd2026-01-08WarningsExact identifier
unii: T7J046YI2B
Creosote Combination 9254CREOSOTE COMBINATIONProfessional Complementary Health Formulas9248c4d5-75a5-4b52-b6b1-b2b8af8da8272026-01-08WarningsExact identifier
unii: T7J046YI2B

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.