FDA.reportPublic FDA data

CardCare

Manufacturer
Newton Laboratories, Inc.
Effective date
2023-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:20

Label at a glance#

ProductCardCare
Active ingredientLYCOPUS VIRGINICUS, ANEMONE PULSATILLA, VIPERA BERUS VENOM, ECHINACEA, UNSPECIFIED, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, BARIUM CARBONATE, VALERIAN, BRYONIA ALBA ROOT, ARSENIC TRIOXIDE, BENZOIC ACID, CHELIDONIUM MAJUS, HYDROFLUORIC ACID, POTASSIUM IODIDE, LACHESIS MUTA VENOM, STRYCHNOS NUX-VOMICA SEED, MICRURUS CORALLINUS VENOM, LYTTA VESICATORIA, CEANOTHUS AMERICANUS LEAF, CHIONANTHUS VIRGINICUS BARK, CONVALLARIA MAJALIS, DIGITALIS, NITROGLYCERIN, NAJA NAJA VENOM, CALCIUM FLUORIDE, GOLD, BERBERIS VULGARIS ROOT BARK, CINCHONA OFFICINALIS BARK, CROTALUS HORRIDUS HORRIDUS VENOM, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, TOXICODENDRON PUBESCENS LEAF
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms such as fear, cold hands & feet, headache, weakness, sallow skin and palpitations.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal of Echinacea 6x, Hypericum 6x, Valeriana 6x, Aconitum nap. 15x, Arsenicum alb. 15x, Aur. met. 15x, Baryta carb. 15x, Benzoicum ac. 15x, Berber. vulg. 15x, Bryonia 15x, Calc. fluor. 15x, Cantharis 15x, Ceanothus 15x, Chelidonium maj. 15x, Chionanthus 15x, Cinchona 15x, Convallaria 15x, Crotalus hor. 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Hydrofluoricum ac. 15x, Kali iod. 15x, Lachesis 15x, Lycopus 15x, Naja 15x, Nux vom. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Vipera 16x, Elaps 30x.

OTC - PURPOSE SECTION

Formulated for symptoms such as fear, cold hands & feet, headache, weakness, sallow skin and palpitations.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4853-1CardCare30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4853CARDCARE (ECHINACEA, HYPERICUM, VALERIANA, ACONITUM NAP., ARSENICUM ALB., AUR. MET., BARYTA CARB., BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. FLUOR., CANTHARIS, CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, CONVALLARIA, CROTALUS HOR., DIGITALIS, GELSEMIUM, GLONOINUM, HYDROFLUORICUM AC. KALI IOD., LACHESIS, LYCOPUS, NAJA, NUX VOM., PHOS., PULSATILLA, RHUS TOX., VIPERA, ELAPS.) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20230926_06342201-f0b4-de0d-e063-6294a90a5621.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-485355714-4853-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
LYCOPUS VIRGINICUSTWH5125Q6FACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
VIPERA BERUS VENOM0ORO6NCA4MACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
BARIUM CARBONATE6P669D8HQ8ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
VALERIANJWF5YAW3QWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BENZOIC ACID8SKN0B0MIMACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
HYDROFLUORIC ACIDRGL5YE86CZACTIM
POTASSIUM IODIDE1C4QK22F9JACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
MICRURUS CORALLINUS VENOMV0S6H36980ACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
CHIONANTHUS VIRGINICUS BARKS9Y4B22U2EACTIB
CONVALLARIA MAJALISQHH4HVF5QEACTIB
DIGITALISF1T8QT9U8BACTIB
NITROGLYCERING59M7S0WS3ACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
GOLD79Y1949PYOACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
PHOSPHORUS27YLU75U4WACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CardCareECHINACEA, HYPERICUM, VALERIANA, ACONITUM NAP., ARSENICUM ALB., AUR. MET., BARYTA CARB., BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. FLUOR., CANTHARIS, CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, CONVALLARIA, CROTALUS HOR., DIGITALIS, GELSEMIUM, GLONOINUM, HYDROFLUORICUM AC. KALI IOD., LACHESIS, LYCOPUS, NAJA, NUX VOM., PHOS., PULSATILLA, RHUS TOX., VIPERA, ELAPS.Newton Laboratories, Inc.06342201-f0b4-de0d-e063-6294a90a56212023-09-25WarningsExact identifier
ndc (package): 55714-4853-1
ndc (product): 55714-4853
ndc11 (package): 55714485301
spl id: 0634351f-fae4-a8e3-e063-6294a90a3b60
spl set id: 06342201-f0b4-de0d-e063-6294a90a5621

Reported adverse events (FAERS/openFDA)#

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