Indications & Usage Section
Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations.
Dust - Mold - Dander
FDA Label NDC 55714-2310
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 Dust - Mold - Dander (NDC 55714-2310). 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, otc - purpose section, inactive ingredient section, questions section, warnings section, otc - pregnancy or breast feeding 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 (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.
Otc - Active Ingredient Section
Allersodes 60x, Allersodes 15x, Candida alb. 15x, Histaminum hydrochloricum 15x, Torula cerevisiae 15x, Ustilago maidis 15x, Antimon. crud. 10x, Apis mel. 10x, Arsenicum alb. 10x, Baptisia 10x, Blatta orientalis 10x, Bromium 10x, Bryonia 10x, Carduus ben. 10x, Chelidonium maj. 10x, Cinchona 10x, Ipecac. 10x, Lycopodium 10x, Nux vom. 10x, Podoph. pelt. 10x, Rhus tox. 10x, Silicea 10x, Iris versicolor 3x, Solidago 3x.
Otc - Purpose Section
Formulated for associated symptoms such as labored breathing, congestion, sneezing, runny nose, watery eyes and skin irritations.
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: Keep our 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 (N056 L01)
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