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 
Newton Laboratories, Inc.

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.

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Prime +

 INDICATIONS AND USAGE SECTION

Prime+    Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin. 

DOSAGE AND ADMINISTRATION SECTION

Directions:  Adults, take 6 pellets orally one to four times daily or as directed by a healthcare professional. Sensitive persons begin with 1 pellet and gradually increase to full dose.

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

Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.

QUESTIONS? SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

package 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-1105
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Chaste Tree (UNII: 433OSF3U8A) (Chaste Tree - UNII:433OSF3U8A) Chaste Tree10 [hp_X]  in 1 g
Garlic (UNII: V1V998DC17) (Garlic - UNII:V1V998DC17) Garlic10 [hp_X]  in 1 g
Ambergris (UNII: XTC0D02P6C) (Ambergris - UNII:XTC0D02P6C) Ambergris10 [hp_X]  in 1 g
Angelica Sinensis Root (UNII: B66F4574UG) (Angelica Sinensis Root - UNII:B66F4574UG) Angelica Sinensis Root10 [hp_X]  in 1 g
American Ginseng (UNII: 8W75VCV53Q) (American Ginseng - UNII:8W75VCV53Q) American Ginseng10 [hp_X]  in 1 g
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana10 [hp_X]  in 1 g
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV) Arsenic Trioxide10 [hp_X]  in 1 g
Avena Sativa Flowering Top (UNII: MA9CQJ3F7F) (Avena Sativa Flowering Top - UNII:MA9CQJ3F7F) Avena Sativa Flowering Top10 [hp_X]  in 1 g
Baptisia Tinctoria Root (UNII: 5EF0HWI5WU) (Baptisia Tinctoria Root - UNII:5EF0HWI5WU) Baptisia Tinctoria Root10 [hp_X]  in 1 g
Barium Carbonate (UNII: 6P669D8HQ8) (Barium Cation - UNII:V645272HLN) Barium Carbonate10 [hp_X]  in 1 g
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B) Bryonia Alba Root10 [hp_X]  in 1 g
Lytta Vesicatoria (UNII: 3Q034RO3BT) (Lytta Vesicatoria - UNII:3Q034RO3BT) Lytta Vesicatoria10 [hp_X]  in 1 g
Lachesis Muta Venom (UNII: VSW71SS07I) (Lachesis Muta Venom - UNII:VSW71SS07I) Lachesis Muta Venom10 [hp_X]  in 1 g
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479) Lycopodium Clavatum Spore10 [hp_X]  in 1 g
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919) Strychnos Nux-vomica Seed10 [hp_X]  in 1 g
Phosphoric Acid (UNII: E4GA8884NN) (Phosphoric Acid - UNII:E4GA8884NN) Phosphoric Acid10 [hp_X]  in 1 g
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV) Pulsatilla Vulgaris10 [hp_X]  in 1 g
Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top10 [hp_X]  in 1 g
Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto10 [hp_X]  in 1 g
Selenium (UNII: H6241UJ22B) (Selenium - UNII:H6241UJ22B) Selenium10 [hp_X]  in 1 g
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc10 [hp_X]  in 1 g
Ginkgo (UNII: 19FUJ2C58T) (Ginkgo - UNII:19FUJ2C58T) Ginkgo3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sucrose (UNII: C151H8M554)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-1105-128.35 g in 1 BOTTLE, GLASS
2NDC:55714-1105-256.7 g in 1 BOTTLE, GLASS
3NDC:55714-1105-07.08 g in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-1105)

Revised: 3/2011
Document Id: a36044af-cc69-5ca4-22d0-2f284b542ab0
Set id: f509acb7-073e-3bb3-adb0-3440d300b1a9
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.