Indications And Usage Section
Formulated for associated symptoms such as dryness, irritation, inflammation, pain and hoarseness.
Throat Care Liquid
FDA Label NDC 55714-4794
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 Throat Care (NDC 55714-4794). 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 and 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.
Otc - Active Ingredient Section
Equal parts of Echinacea 6x, Aconitum nap. 15x, Apis mel. 15x, Arum drac. 15x, Belladonna 15x, Bryonia 15x, Cajuputum 15x, Ferrum phos. 15x, Glycyrrhiza 15x, Kali bic. 15x, Lachesis 15x, Menta pip. 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Nitricum ac. 15x, Nux vom. 15x, Phos. 15x, Phytolacca 15x, Pulsatilla 15x, Spongia 15x, Stannum met. 15x, Sticta 15x, Thuja occ. 15x, Ulmus fulv. 15x, Verbascum 15x.
Otc - Purpose Section
Formulated for associated symptoms such as dryness, irrtiation, inflammation, pain and hoarseness.
Inactive Ingredient Section
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
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.
Package Label
Package Label (R026 L01)
* Please review the disclaimer below.
