Label: COLD - COUGH- influenzinum, aralia quinquefolia, arsenicum alb., bryonia, euphrasia, gaultheria procumbens, gelsemium, hepar sulph. calc., histaminum hydrochloricum, hydrastis, kali bic., merc. viv., phosphorus, pulsatilla, rhus toxicodendron, sabadilla, salvia, sticta, verbascum, echinacea pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-4421-1, 55714-4421-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN PRESCRIPTION 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 June 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
- DOSAGE & ADMINISTRATION SECTION
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ACTIVE INGREDIENT SECTION
Influenzinum 35x, Aralia quinquefolia 20x, Arsenicum alb. 20x, Bryonia 20x, Euphrasia 20x, Gaultheria procumbens 20x, Gelsemium 20x, Hepar sulph. calc. 20x, Histaminum hydrochloricum 20x, Hydrastis 20x, Kali bic. 20x, Merc. viv. 20x, Phosphorus 20x, Pulsatilla 20x, Rhus toxicodendron 20x, Sabadilla 20x, Salvia 20x, Sticta 20x, Verbascum 20x, Echinacea 8x, Hydrastis 8x, Echinacea 3x, Hydrastis 3x.
- PURPOSE SECTION
- INACTIVE INGREDIENT SECTION
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QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256 - WARNINGS SECTION
- PREGNANCY OR BREAST FEEDING SECTION
- KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL.
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INGREDIENTS AND APPEARANCE
COLD - COUGH
influenzinum, aralia quinquefolia, arsenicum alb., bryonia, euphrasia, gaultheria procumbens, gelsemium, hepar sulph. calc., histaminum hydrochloricum, hydrastis, kali bic., merc. viv., phosphorus, pulsatilla, rhus toxicodendron, sabadilla, salvia, sticta, verbascum, echinacea pelletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4421 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 35 [hp_X] in 1 g American Ginseng (UNII: 8W75VCV53Q) (American Ginseng - UNII:8W75VCV53Q) American Ginseng 20 [hp_X] in 1 g Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 20 [hp_X] in 1 g Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 20 [hp_X] in 1 g Euphrasia Stricta (UNII: C9642I91WL) (Euphrasia Stricta - UNII:C9642I91WL) Euphrasia Stricta 20 [hp_X] in 1 g Gaultheria Procumbens Top (UNII: 830295X963) (Gaultheria Procumbens Top - UNII:830295X963) Gaultheria Procumbens Top 20 [hp_X] in 1 g Gelsemium Sempervirens Root (UNII: 639KR60Q1Q) (Gelsemium Sempervirens Root - UNII:639KR60Q1Q) Gelsemium Sempervirens Root 20 [hp_X] in 1 g Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide 20 [hp_X] in 1 g Histamine Dihydrochloride (UNII: 3POA0Q644U) (Histamine - UNII:820484N8I3) Histamine Dihydrochloride 20 [hp_X] in 1 g Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 20 [hp_X] in 1 g Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate 20 [hp_X] in 1 g Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury 20 [hp_X] in 1 g Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 20 [hp_X] in 1 g Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 20 [hp_X] in 1 g Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 20 [hp_X] in 1 g Schoenocaulon Officinale Seed (UNII: 6NAF1689IO) (Schoenocaulon Officinale Seed - UNII:6NAF1689IO) Schoenocaulon Officinale Seed 20 [hp_X] in 1 g Sage (UNII: 065C5D077J) (Sage - UNII:065C5D077J) Sage 20 [hp_X] in 1 g Lobaria Pulmonaria (UNII: D1YM0P5Z2T) (Lobaria Pulmonaria - UNII:D1YM0P5Z2T) Lobaria Pulmonaria 20 [hp_X] in 1 g Verbascum Thapsus (UNII: C9TD27U172) (Verbascum Thapsus - UNII:C9TD27U172) Verbascum Thapsus 20 [hp_X] in 1 g Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 8 [hp_X] in 1 g Influenza B Virus (UNII: 1314JZ2X6W) (Influenza B Virus - UNII:1314JZ2X6W) Influenza B Virus 35 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Sucrose (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4421-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-4421-2 56.7 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-4421)