Indications & Usage Section
Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.
Sinu-s Liquid
FDA Label NDC 55714-4778
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 Sinu-s (NDC 55714-4778). 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) one to four times daily or as directed by a health professional.
Otc - Active Ingredient Section
Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Arsenicum iodatum 15x, Bryonia 15x, Cistus canadensis 15x, Hepar sulphuris calcareum 15x, Histaminum hydrochloricum 15x, Hydrastis canadensis 15x, Iodium 15x, Kali bichromicum 15x, Kali iodatum 15x, Mercurius iodatus ruber 15x, Mercurius vivus 15x, Nux vomica 15x, Phosphorus 15x, Pulsatilla 15x, Sabadilla 15x, Sticta pulmonaria 15x, Verbascum thapsus 15x, Sinusitisinum 16x.
Otc - Purpose Section
Formulated for symptoms such as stuffy nose, cough, sinus pressure and low-grade fever.
Inactive Ingredient Section
I nactive 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
Keep out of reach of children.
Package Label
Package Label (R010 L01)
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