Indications & Usage Section
Formulated for associated symptoms such as breast tenderness, nursing discomfort and pre-menstrual swelling.
Breast Care - Fibrocystic Liquid
FDA Label NDC 55714-4828
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Newton Laboratories, Inc. for the product Breast Care - Fibrocystic (NDC 55714-4828). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage section, dosage & administration section, otc - active ingredient section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration Section
Directions: Ages 12 and up take 6 drops by mouth one to four times daily or as directed by a health professional.
Otc - Active Ingredient Section
Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Apis mel. 15x, Asterias 15x, Belladonna 15x, Bryonia 15x, Bufo 15x, Calc. carb. 15x, Chamomilla 15x, Chimaphila umb. 15x, Cinchona 15x, Conium 15x, Croton 15x, Echinacea 15x, Graphites 15x, Helonias 15x, Lachesis 15x, Merc. viv. 15x, Phellandrium 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Sanguinaria 15x, Silicea 15x.
Inactive Ingredient Section
Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
Questions Section
newtonlabs.net - Questions? 800 448-7256
Newton Laboratories, Inc. FDA Est. # 1051203 - Conyers, GA 30013
Warnings Section
WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.
Otc - Pregnancy Or Breast Feeding Section
If pregnant or breast-feeding, ask a doctor before use.
Otc - Keep Out Of Reach Of Children Section
Keep out of reach of children.
Package Label
Package Label (R054 L01)
* Please review the disclaimer below.
