Indications & Usage Section
Aches - Pains: Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.
Aches - Pains Pellet
FDA Label NDC 55714-2383
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 Aches - Pains (NDC 55714-2383). 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, otc - active ingredient section, otc - purpose section, inactive ingredient section, otc - questions section, otc - pregnancy or breast feeding section, otc - keep out of reach of children section, dosage & administration section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient Section
Active Ingredients: Equal parts of Hamamelis 6x, Phytolacca 6x, Ruta 6x, Taraxacum 6x, Aconitum nap. 15x, Arg. nit. 15x, Arnica 15x, Bryonia 15x, Colchicum 15x, Guaiacum 15x, Hypericum 15x, Kalmia 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Rhus tox. 15x, Ruta 15x, Sarcolacticum ac. 15x, Sticta 15x, Stramonium 15x.
Otc - Purpose Section
Formulated for symptoms associated with bruises, strains and overexertion such as pain, stiffness and inflammation.
Inactive Ingredient Section
Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.
Otc - Questions Section
newtonlabs.net ~ Questions? 800-448-7256
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013
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.
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 drop and gradually increase to full dose.
Warnings Section
Warnings: 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.
Package Label
Package Label (N019 P01)
* Please review the disclaimer below.
