FDA Label for Food Allergy - Additive

View Indications, Usage & Precautions

Food Allergy - Additive Product Label

The following document was submitted to the FDA by the labeler of this product Newton Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Indications & Usage Section



Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.


Dosage & Administration Section



Directions:   Ages 12 and up, take 6 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional.  Under age 2, crush/dissolve pellets in purified water.  Sensitive persons begin with 1 pellet and gradually increase to full dose.


Otc - Active Ingredient Section



Allersodes 60x, Allersodes 15x,Histaminum hydrochloricum 15x, Lycopersicum 15x, Saccharinum 15x, Sac. lac. 15x, Solanum tub. 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Aconitum nap. 10x, Antimon.crud. 10x, Arsenicum alb. 10x, Baptisia 10x, Cinchona 10x, Gelsemium 10x, Ipecac. 10x, Lachesis 10x, Ledum 10x, Lycopodium 10x, Nat. mur. 10x, Phos. 10x, Podoph. pelt. 10x, Pulsatilla 10x, Rhus tox. 10x, Sepia 10x, Sulphur 10x, Urtica ur. 10x, Iris vers. 3x, Solidago 3x.


Otc - Purpose Section



Formulated for associated symptoms such as itching, swelling, headaches, labored breathing and digestive upset.


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:  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




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