Label: PRIME PLUS- agnus, allium sativum, ambra, angelica sinensis radix, aralia quinquefolia, arnica, arsenicum alb., avena, baptisia, baryta carb., bryonia, cantharis, lachesis, lycopodium, nux vom., phosphoricum ac., pulsatilla, ruta, sabal, selenium, zinc. met., ginkgo pellet
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-1105-0, 55714-1105-1, 55714-1105-2 - 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 1, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS AND USAGE SECTION
- DOSAGE AND ADMINISTRATION SECTION
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OTC ACTIVE INGREDIENT SECTION
Agnus 10x, Allium sativum 10x, Ambra10x, Angelica sinensis radix 10x, Aralia quinquefolia 10x, Arnica 10x, Arsenicum alb. 10x, Avena 10x, Baptisia 10x, Baryta carb. 10x, Bryonia 10x, Cantharis 10x, Lachesis 10x, Lycopodium 10x, Nux vom.10x, Phosphoricum ac. 10x, Pulsatilla 10x, Ruta 10x, Sabal 10x, Selenium 10x, Zinc. met. 10x, Ginkgo 3x, Ruta 3x.
- OTC 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
PRIME PLUS
agnus, allium sativum, ambra, angelica sinensis radix, aralia quinquefolia, arnica, arsenicum alb., avena, baptisia, baryta carb., bryonia, cantharis, lachesis, lycopodium, nux vom., phosphoricum ac., pulsatilla, ruta, sabal, selenium, zinc. met., ginkgo pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-1105 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chaste Tree (UNII: 433OSF3U8A) (Chaste Tree - UNII:433OSF3U8A) Chaste Tree 10 [hp_X] in 1 g Garlic (UNII: V1V998DC17) (Garlic - UNII:V1V998DC17) Garlic 10 [hp_X] in 1 g Ambergris (UNII: XTC0D02P6C) (Ambergris - UNII:XTC0D02P6C) Ambergris 10 [hp_X] in 1 g Angelica Sinensis Root (UNII: B66F4574UG) (Angelica Sinensis Root - UNII:B66F4574UG) Angelica Sinensis Root 10 [hp_X] in 1 g American Ginseng (UNII: 8W75VCV53Q) (American Ginseng - UNII:8W75VCV53Q) American Ginseng 10 [hp_X] in 1 g Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana 10 [hp_X] in 1 g Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide 10 [hp_X] in 1 g Avena Sativa Flowering Top (UNII: MA9CQJ3F7F) (Avena Sativa Flowering Top - UNII:MA9CQJ3F7F) Avena Sativa Flowering Top 10 [hp_X] in 1 g Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root 10 [hp_X] in 1 g Barium Carbonate (UNII: 6P669D8HQ8) (Barium Cation - UNII:V645272HLN) Barium Carbonate 10 [hp_X] in 1 g Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root 10 [hp_X] in 1 g Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria 10 [hp_X] in 1 g Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom 10 [hp_X] in 1 g Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore 10 [hp_X] in 1 g Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed 10 [hp_X] in 1 g Phosphoric Acid (UNII: E4GA8884NN) (Phosphoric Acid - UNII:E4GA8884NN) Phosphoric Acid 10 [hp_X] in 1 g Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris 10 [hp_X] in 1 g Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top 10 [hp_X] in 1 g Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto 10 [hp_X] in 1 g Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium 10 [hp_X] in 1 g Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 10 [hp_X] in 1 g Ginkgo (UNII: 19FUJ2C58T) (Ginkgo - UNII:19FUJ2C58T) Ginkgo 3 [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:55714-1105-1 28.35 g in 1 BOTTLE, GLASS 2 NDC:55714-1105-2 56.7 g in 1 BOTTLE, GLASS 3 NDC:55714-1105-0 7.08 g in 1 BOTTLE, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/01/2011 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-1105)
