Label: COLD - COUGH- influenza a virus, influenza b virus, antimon. tart., arsenicum alb., bryonia, chelidonium majus, cinchona, drosera, eucalyptus, histaminum hydrochloricum, hydrastis, kali bic., kali carb.,kali iod., myrrha, nat. sulphuricum, nux vom., phosphorus, pulsatilla, rumex crisp., sambucus nig., spongia, tussilago farfara, verbascum, echinacea, lappa liquid
- NDC Code(s): 55714-4767-1
- 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 March 17, 2022
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- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Lappa 6x, Antimon. tart. 15x, Arsenicum alb. 15x, Bryonia 15x, Chelidonium majus 15x, Cinchona 15x, Drosera 15x, Eucalyptus 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Kali carb. 15x, Kali iod. 15x, Myrrha 15x, Nat. sulphuricum 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Rumex crisp. 15x, Sambucus nig.15x, Spongia 15x, Tussilago farfara 15x, Verbascum 15x, Influenzinum 30x.
- OTC - PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
- QUESTIONS SECTION
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
COLD - COUGH
influenza a virus, influenza b virus, antimon. tart., arsenicum alb., bryonia, chelidonium majus, cinchona, drosera, eucalyptus, histaminum hydrochloricum, hydrastis, kali bic., kali carb.,kali iod., myrrha, nat. sulphuricum, nux vom., phosphorus, pulsatilla, rumex crisp., sambucus nig., spongia, tussilago farfara, verbascum, echinacea, lappa liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-4767 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS 30 [hp_X] in 1 mL ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE 15 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN) CHELIDONIUM MAJUS 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 DROSERA ANGLICA (UNII: J61BY05EGY) (DROSERA ANGLICA - UNII:J61BY05EGY) DROSERA ANGLICA 15 [hp_X] in 1 mL EUCALYPTUS GUM (UNII: 72T9EZC2VX) (EUCALYPTUS GUM - UNII:72T9EZC2VX) EUCALYPTUS GUM 15 [hp_X] in 1 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 15 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 15 [hp_X] in 1 mL POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 15 [hp_X] in 1 mL POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE 15 [hp_X] in 1 mL POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION 15 [hp_X] in 1 mL MYRRH (UNII: JC71GJ1F3L) (MYRRH - UNII:JC71GJ1F3L) MYRRH 15 [hp_X] in 1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 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 PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 15 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) ANEMONE PULSATILLA 15 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 15 [hp_X] in 1 mL SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U) SAMBUCUS NIGRA FLOWERING TOP 15 [hp_X] in 1 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 15 [hp_X] in 1 mL TUSSILAGO FARFARA (UNII: 0JXZ63016V) (TUSSILAGO FARFARA - UNII:0JXZ63016V) TUSSILAGO FARFARA 15 [hp_X] in 1 mL VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS 15 [hp_X] in 1 mL ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED 6 [hp_X] in 1 mL ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 6 [hp_X] in 1 mL INFLUENZA B VIRUS (UNII: 1314JZ2X6W) (INFLUENZA B VIRUS - UNII:1314JZ2X6W) INFLUENZA B VIRUS 30 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4767-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/02/2019 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-4767)
