BREAST HELP - bufo bufo cutaneous gland, apis mellifera, asterias rubens, atropa belladonna, bryonia alba root, oyster shell calcium carbonate, crude, matricaria recutita, chimaphila umbellata, cinchona officinalis bark, conium maculatum flowering top, croton tiglium seed, echinacea, unspecified, graphite, chamaelirium luteum root, lachesis muta venom, mercury, oenanthe aquatica fruit, phosphorus, phytolacca americana root, pulsatilla vulgaris, sanguinaria canadensis root, silicon dioxide, hamamelis virginiana root bark/stem bark, ruta graveolens flowering top and taraxacum officinale 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.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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INDICATIONS & USAGE SECTION

Breast Help   Formulated for symptoms associated with breast conditions as well as the discomfort experienced by nursing mothers.

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. Sensitive persons begin with1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Bufo rana 15x, Apis mel. 10x, Asterias rubens 10x, Belladonna 10x, Bryonia 10x, Calc. carb. 10x, Chamomilla 10x, Chimaphila umbellata 10x, Cinchona 10x, Conium 10x, Croton 10x, Echinacea 10x, Graphites 10x, Helonias dioica 10x, Lachesis 10x, Merc. viv. 10x, Phellandrium aquaticum 10x, Phosphorus 10x, Phytolacca 10x, Pulsatilla 10x, Sanguinaria 10x, Silicea 10x, Hamamelis 3x, Phytolacca 3x, Ruta 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with breast conditions as well as the discomfort experienced by nursing mothers.

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.  

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

BREAST HELP  
bufo rana, apis mel., asterias rubens, belladonna, bryonia, calc. carb., chamomilla, chimaphila umbellata, cinchona, conium, croton, echinacea, graphites, helonias dioica, lachesis, merc. viv., phellandrium aquaticum phosphorus, phytolacca, pulsatilla, sanguinaria, silicea, hamamelis, ruta, taraxacum liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2326
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bufo Bufo Cutaneous Gland (Bufo Bufo Cutaneous Gland) Bufo Bufo Cutaneous Gland15 [hp_X]  in 1 mL
Apis Mellifera (Apis Mellifera) Apis Mellifera10 [hp_X]  in 1 mL
Asterias Rubens (Asterias Rubens) Asterias Rubens10 [hp_X]  in 1 mL
Atropa Belladonna (Atropa Belladonna) Atropa Belladonna10 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root10 [hp_X]  in 1 mL
Oyster Shell Calcium Carbonate, Crude (Oyster Shell Calcium Carbonate, Crude) Oyster Shell Calcium Carbonate, Crude10 [hp_X]  in 1 mL
Matricaria Recutita (Matricaria Recutita) Matricaria Recutita10 [hp_X]  in 1 mL
Chimaphila Umbellata (Chimaphila Umbellata) Chimaphila Umbellata10 [hp_X]  in 1 mL
Cinchona Officinalis Bark (Cinchona Officinalis Bark) Cinchona Officinalis Bark10 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (Conium Maculatum Flowering Top) Conium Maculatum Flowering Top10 [hp_X]  in 1 mL
Croton Tiglium Seed (Croton Tiglium Seed) Croton Tiglium Seed10 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified10 [hp_X]  in 1 mL
Graphite (Graphite) Graphite10 [hp_X]  in 1 mL
Chamaelirium Luteum Root (Chamaelirium Luteum Root) Chamaelirium Luteum Root10 [hp_X]  in 1 mL
Lachesis Muta Venom (Lachesis Muta Venom) Lachesis Muta Venom10 [hp_X]  in 1 mL
Mercury (Mercury) Mercury10 [hp_X]  in 1 mL
Oenanthe Aquatica Fruit (Oenanthe Aquatica Fruit) Oenanthe Aquatica Fruit10 [hp_X]  in 1 mL
Phosphorus (Phosphorus) Phosphorus10 [hp_X]  in 1 mL
Phytolacca Americana Root (Phytolacca Americana Root) Phytolacca Americana Root10 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris10 [hp_X]  in 1 mL
Sanguinaria Canadensis Root (Sanguinaria Canadensis Root) Sanguinaria Canadensis Root10 [hp_X]  in 1 mL
Silicon Dioxide (Silicon Dioxide) Silicon Dioxide10 [hp_X]  in 1 mL
Hamamelis Virginiana Root Bark/stem Bark (Hamamelis Virginiana Root Bark/stem Bark) Hamamelis Virginiana Root Bark/stem Bark3 [hp_X]  in 1 mL
Ruta Graveolens Flowering Top (Ruta Graveolens Flowering Top) Ruta Graveolens Flowering Top3 [hp_X]  in 1 mL
Taraxacum Officinale (Taraxacum Officinale) Taraxacum Officinale3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-2326-129.57 mL in 1 BOTTLE, GLASS
2NDC:55714-2326-259.14 mL in 1 BOTTLE, GLASS
3NDC:55714-2326-0.5 mL 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(55714-2326), API MANUFACTURE(55714-2326)

Revised: 03/2011
Document Id: 44428a66-cbe2-ec44-fcea-99696630fe83
Set id: 84ca6498-7cef-72c4-c0b4-18aa3ee182c9
Version: 1
Effective Time: 20110301
 
Newton Laboratories, Inc.