Label: SINUSITIS- arsenicum iodatum, bryonia, cistus canadensis, hepar sulph. calc., histaminum hydrochloricum, hydrastis, iodium, kali bic., kali iod., merc. iod. rub., merc. viv., nux vom., phosphorus, pulsatilla, sabadilla, sticta, verbascum, echinacea liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-4418-1, 55714-4418-2 - Packager: Newton Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
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
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- PRODUCT NAME & INDICATIONS SECTION
- DIRECTION SECTION
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ACTIVE INGREDIENT SECTION
Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulph. calc. 15x, Histaminum hydrochloricum 15x, Hydrastis 15x, Iodium 15x, Kali bic. 15x, Kali iod.15x, Merc. iod. rub. 15x, Merc. viv. 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta 15x, Verbascum 15x , 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
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
SINUSITIS
arsenicum iodatum, bryonia, cistus canadensis, hepar sulph. calc., histaminum hydrochloricum, hydrastis, iodium, kali bic., kali iod., merc. iod. rub., merc. viv., nux vom., phosphorus, pulsatilla, sabadilla, sticta, verbascum, echinacea liquidProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55714-4418 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Arsenic Triiodide (UNII: 3029988O2T) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Triiodide 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 Helianthemum Canadense (UNII: 46G3W789Q3) (Helianthemum Canadense - UNII:46G3W789Q3) Helianthemum Canadense 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 Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 15 [hp_X] in 1 mL Potassium Dichromate (UNII: T4423S18FM) (Dichromate Ion - UNII:9LKY4BFN2V) Potassium Dichromate 15 [hp_X] in 1 mL Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Potassium Iodide 15 [hp_X] in 1 mL Mercuric Iodide (UNII: R03O05RB0P) (Mercuric Cation - UNII:ED30FJ8Y42) Mercuric Iodide 15 [hp_X] in 1 mL Mercury (UNII: FXS1BY2PGL) (Mercury - UNII:FXS1BY2PGL) Mercury 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 Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 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 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 3 [hp_X] in 1 mL Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-4418-1 29.57 mL in 1 BOTTLE, GLASS 2 NDC:55714-4418-2 59.14 mL 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(55714-4418) , API MANUFACTURE(55714-4418)