MENORRHAGIA - aletris, apocynum, cinchona, cinnamomum, conium, helonias dioica, lilium, millefolium, phosphorus, secale, thlaspi, trillium pendulum, apis mel., hamamelis, hydrastis liquid 
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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Menorrhagia

INDICATIONS & USAGE SECTION

Menorrhagia  Formulated for associated symptoms such as uterine fibroids, uterine polyps, endometriosis and other uterine and ovarian conditions.

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally one to four times daily or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

Aletris 15x, Apocynum 15x, Cinchona 15x, Cinnamomum 15x, Conium 15x, Helonias dioica 15x, Lilium 15x, Millefolium 15x, Phosphorus 15x, Secale 15x, Thlaspi 15x, Trillium pendulum 15x, Apis mel. 3x, Hamamelis 3x, Hydrastis 3x.

PURPOSE SECTION

Formulated for associated symptoms such as uterine fibroids, uterine polyps, endometriosis and other uterine and ovarian conditions.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:  USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.

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.

 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. 

 KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

Package Label

MENORRHAGIA  
aletris, apocynum, cinchona, cinnamomum, conium, helonias dioica, lilium, millefolium, phosphorus, secale, thlaspi, trillium pendulum, apis mel., hamamelis, hydrastis liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55714-4520
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aletris Farinosa Root (UNII: O021JGR97X) (Aletris Farinosa Root - UNII:O021JGR97X) Aletris Farinosa Root15 [hp_X]  in 1 mL
Apocynum Cannabinum Root (UNII: 2F92409L9Z) (Apocynum Cannabinum Root - UNII:2F92409L9Z) Apocynum Cannabinum Root15 [hp_X]  in 1 mL
Cinchona Officinalis Bark (UNII: S003A158SB) (Cinchona Officinalis Bark - UNII:S003A158SB) Cinchona Officinalis Bark15 [hp_X]  in 1 mL
Cinnamon (UNII: 5S29HWU6QB) (Cinnamon - UNII:5S29HWU6QB) Cinnamon15 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (UNII: Q28R5GF371) (Conium Maculatum Flowering Top - UNII:Q28R5GF371) Conium Maculatum Flowering Top15 [hp_X]  in 1 mL
Chamaelirium Luteum Root (UNII: DQV54Y5H3U) (Chamaelirium Luteum Root - UNII:DQV54Y5H3U) Chamaelirium Luteum Root15 [hp_X]  in 1 mL
Lilium Lancifolium Whole Flowering (UNII: X67Z2963PI) (Lilium Lancifolium Whole Flowering - UNII:X67Z2963PI) Lilium Lancifolium Whole Flowering15 [hp_X]  in 1 mL
Achillea Millefolium (UNII: 2FXJ6SW4PK) (Achillea Millefolium - UNII:2FXJ6SW4PK) Achillea Millefolium15 [hp_X]  in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus15 [hp_X]  in 1 mL
Claviceps Purpurea Sclerotium (UNII: 01G9XEA93N) (Claviceps Purpurea Sclerotium - UNII:01G9XEA93N) Claviceps Purpurea Sclerotium15 [hp_X]  in 1 mL
Capsella Bursa-pastoris (UNII: W0X9457M59) (Capsella Bursa-pastoris - UNII:W0X9457M59) Capsella Bursa-pastoris15 [hp_X]  in 1 mL
Trillium Erectum Root (UNII: AHW6F0T2X0) (Trillium Erectum Root - UNII:AHW6F0T2X0) Trillium Erectum Root15 [hp_X]  in 1 mL
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera3 [hp_X]  in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/stem Bark3 [hp_X]  in 1 mL
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-4520-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-4520-259.14 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4520)

Revised: 6/2011
Document Id: 1bfd88ef-e0ef-7e9d-3ce8-3db9d1c5836b
Set id: 6c0af311-292c-0f28-8a11-de712055e875
Version: 3
Effective Time: 20110601
 
Newton Laboratories, Inc.