Label: FLU CARE- influenza a virus, influenza b virus, histaminum hydrochloricum, aconitum nap., aralia quinquefolia, arsenicum alb., baptisia, bryonia, cinchona, eupatorium perf., gelsemium, ipecac., kali carb., nux vom., phosphorus, rhus toxicodendron, echinacea liquid
- NDC Code(s): 55714-2442-1
- 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 November 25, 2020
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
- OTC - ACTIVE INGREDIENT SECTION
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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INGREDIENTS AND APPEARANCE
FLU CARE
influenza a virus, influenza b virus, histaminum hydrochloricum, aconitum nap., aralia quinquefolia, arsenicum alb., baptisia, bryonia, cinchona, eupatorium perf., gelsemium, ipecac., kali carb., nux vom., phosphorus, rhus toxicodendron, echinacea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2442 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 15 [hp_X] in 1 mL ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 10 [hp_X] in 1 mL AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG 10 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 10 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 10 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 10 [hp_X] in 1 mL EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 10 [hp_X] in 1 mL GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 10 [hp_X] in 1 mL IPECAC (UNII: 62I3C8233L) (IPECAC - UNII:62I3C8233L) IPECAC 10 [hp_X] in 1 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 10 [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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS 30 [hp_X] in 1 mL INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA B VIRUS 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2442-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/31/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/31/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-2442)