Label: COLD - SINUS- influenza a virus, influenza b virus, aralia quinquefolia, arsenicum alb., bryonia, euphrasia, gaultheria procubens, gelsemium, hepar sulph. calc., histaminum hydrochloricum, hydrastis, kali bic., merc. viv., phosphorus, pulsatilla, rhus toxicodendron, sabadilla, salvia, sticta, verbascum, echinacea liquid
- NDC Code(s): 55714-2406-0, 55714-2406-1, 55714-2406-2
- 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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- Official Label (Printer Friendly)
- OTC - PURPOSE SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- WARNINGS SECTION
- QUESTIONS SECTION
- INACTIVE INGREDIENT SECTION
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OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis 6x, Aralia quin. 15x, Arsenicum alb. 15x, Bryonia 15x, Euphrasia 15x, Gaultheria 15x, Gelsemium 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Kali bic. 15x, Merc. viv. 15x, Phos. 15x, Pulsatilla 15x, Rhus tox. 15x, Sabadilla 15x, Salvia 15x, Sticta 15x, Verbascum 15x, Sinusitisinum 16x, Influenzinum 30x.
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
COLD - SINUS
influenza a virus, influenza b virus, aralia quinquefolia, arsenicum alb., bryonia, euphrasia, gaultheria procubens, gelsemium, hepar sulph. calc., histaminum hydrochloricum, hydrastis, kali bic., merc. viv., phosphorus, pulsatilla, rhus toxicodendron, sabadilla, salvia, sticta, verbascum, echinacea liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2406 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5) SINUSITISINUM 16 [hp_X] in 1 mL INFLUENZA A VIRUS (UNII: R9HH0NDE2E) (INFLUENZA A VIRUS - UNII:R9HH0NDE2E) INFLUENZA A VIRUS 30 [hp_X] in 1 mL AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG 15 [hp_X] in 1 mL ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE 15 [hp_C] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 15 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 15 [hp_X] in 1 mL GAULTHERIA PROCUMBENS TOP (UNII: 830295X963) (GAULTHERIA PROCUMBENS TOP - UNII:830295X963) GAULTHERIA PROCUMBENS TOP 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 CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 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 MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 15 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 15 [hp_X] in 1 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 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 SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 15 [hp_X] in 1 mL SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE 15 [hp_X] in 1 mL LOBARIA PULMONARIA (UNII: D1YM0P5Z2T) (LOBARIA PULMONARIA - UNII:D1YM0P5Z2T) LOBARIA PULMONARIA 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 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:55714-2406-1 30 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/09/2018 2 NDC:55714-2406-2 50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/09/2018 08/01/2019 3 NDC:55714-2406-0 15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 11/09/2018 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/09/2018 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 manufacture(55714-2406)
