Breast Care - Fibrocystic description, usages, side effects, indications, overdosage, supplying and lots more!

Breast Care - Fibrocystic

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Breast Care - Fibrocystic

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Breast Care - Fibrocystic   Formulated for symptoms associated with fibrocystic breasts, mastitis, post-partum and breast-feeding disorders and other related breast 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

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.

PURPOSE SECTION

Formulated for symptoms associated with fibrocystic breasts, mastitis, post-partum and breast-feeding disorders and other related breast 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

Breast Care - Fibrocystic

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 Type Human prescription drug label Item Code (Source) NDC:55714-4506
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BUFO BUFO CUTANEOUS GLAND BUFO BUFO CUTANEOUS GLAND 15 [hp_X]
APIS MELLIFERA APIS MELLIFERA 10 [hp_X]
Asterias Rubens ASTERIAS RUBENS 10 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 10 [hp_X]
BRYONIA ALBA ROOT BRYONIA ALBA ROOT 10 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 10 [hp_X]
CHIMAPHILA UMBELLATA CHIMAPHILA UMBELLATA 10 [hp_X]
Cinchona Officinalis Bark Cinchona Officinalis Bark 10 [hp_X]
Conium Maculatum Flowering Top CONIUM MACULATUM FLOWERING TOP 10 [hp_X]
Croton Tiglium Seed Croton Tiglium Seed 10 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 10 [hp_X]
Graphite GRAPHITE 10 [hp_X]
Chamaelirium Luteum Root Chamaelirium Luteum Root 10 [hp_X]
LACHESIS MUTA VENOM LACHESIS MUTA VENOM 10 [hp_X]
MERCURY Mercury 10 [hp_X]
OENANTHE AQUATICA FRUIT Oenanthe Aquatica Fruit 10 [hp_X]
PHOSPHORUS PHOSPHORUS 10 [hp_X]
PHYTOLACCA AMERICANA ROOT PHYTOLACCA AMERICANA ROOT 10 [hp_X]
PULSATILLA VULGARIS PULSATILLA VULGARIS 10 [hp_X]
SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT 10 [hp_X]
SILICON DIOXIDE 10 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X]
RUTA GRAVEOLENS FLOWERING TOP RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]
TARAXACUM OFFICINALE Taraxacum Officinale 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
ALCOHOL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-4506-1 29.57 in 1 BOTTLE, GLASS
2 NDC:55714-4506-2 59.14 in 1 BOTTLE, GLASS

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-06-01


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