DailyMed - CARDCARE- 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

NDC Code(s): 55714-4853-1
Packager: Newton Laboratories, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 25, 2023

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

Formulated for symptoms such as fear, cold hands & feet, headache, weakness, sallow skin and palpitations.
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DOSAGE & ADMINISTRATION SECTION
Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional.

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

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

Formulated for symptoms such as fear, cold hands & feet, headache, weakness, sallow skin and palpitations.
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INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
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OTC - QUESTIONS SECTION
newtonlabs.net - Questions? 800.448.7256 - Newton Laboratories, Inc. FDA Est # 1051203 Conyers, GA 30013

newtonlabs.net - Questions? 800.448.7256

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

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.
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OTC - PREGNANCY OR BREAST FEEDING SECTION
If - pregnant or breast-feeding, ask a doctor before use.

If pregnant or breast-feeding, ask a doctor before use.
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OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.

Keep out of reach of children.
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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

Product Information

CARDCARE 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-4853
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LYCOPUS VIRGINICUS (UNII: TWH5125Q6F) (LYCOPUS VIRGINICUS - UNII:TWH5125Q6F)	LYCOPUS VIRGINICUS	15 [hp_X] in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	15 [hp_X] in 1 mL
VIPERA BERUS VENOM (UNII: 0ORO6NCA4M) (VIPERA BERUS VENOM - UNII:0ORO6NCA4M)	VIPERA BERUS VENOM	16 [hp_X] in 1 mL
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X] in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X] in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	15 [hp_X] in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	15 [hp_X] in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X] in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X] in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X] in 1 mL
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	15 [hp_X] in 1 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	15 [hp_X] in 1 mL
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	15 [hp_X] in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	15 [hp_X] in 1 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	15 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X] in 1 mL
MICRURUS CORALLINUS VENOM (UNII: V0S6H36980) (MICRURUS CORALLINUS VENOM - UNII:V0S6H36980)	MICRURUS CORALLINUS VENOM	30 [hp_X] in 1 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	15 [hp_X] in 1 mL
CEANOTHUS AMERICANUS LEAF (UNII: 25B1Y14T8N) (CEANOTHUS AMERICANUS LEAF - UNII:25B1Y14T8N)	CEANOTHUS AMERICANUS LEAF	15 [hp_X] in 1 mL
CHIONANTHUS VIRGINICUS BARK (UNII: S9Y4B22U2E) (CHIONANTHUS VIRGINICUS BARK - UNII:S9Y4B22U2E)	CHIONANTHUS VIRGINICUS BARK	15 [hp_X] in 1 mL
CONVALLARIA MAJALIS (UNII: QHH4HVF5QE) (CONVALLARIA MAJALIS - UNII:QHH4HVF5QE)	CONVALLARIA MAJALIS	15 [hp_X] in 1 mL
DIGITALIS (UNII: F1T8QT9U8B) (DIGITALIS - UNII:F1T8QT9U8B)	DIGITALIS	15 [hp_X] in 1 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	15 [hp_X] in 1 mL
NAJA NAJA VENOM (UNII: ZZ4AG7L7VM) (NAJA NAJA VENOM - UNII:ZZ4AG7L7VM)	NAJA NAJA VENOM	15 [hp_X] in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	15 [hp_X] in 1 mL
GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO)	GOLD	15 [hp_X] in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	15 [hp_X] in 1 mL
CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB)	CINCHONA OFFICINALIS BARK	15 [hp_X] in 1 mL
CROTALUS HORRIDUS HORRIDUS VENOM (UNII: YHA2XLJ956) (CROTALUS HORRIDUS HORRIDUS VENOM - UNII:YHA2XLJ956)	CROTALUS HORRIDUS HORRIDUS VENOM	15 [hp_X] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	15 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-4853-1	30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	09/25/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/25/2023

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-4853)

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