Sinufix Liquid
FDA Label NDC 70163-0030

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Naturalcare for the product Sinufix (NDC 70163-0030). 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 active ingredient:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

(in each drop) Hepar Sulphuris Calcareum 20X, 30X 11.9%, Kali Bichromicum 6X, 12X, 20X, 30X 11.9%, Mercurius Iodatus Ruber 12X 11.9%, Spongia Tosta 10X 11.9%, Thuja Occidentalis 6X 11.9%, Antimonium Tartaricum 6X 0.10%, Hepar Sulphuris Calcareum 10X 0.10%.

Purpose:

Hepar Sulphuris Calcareum – congestion, post-nasal drip,* Kali Bichromicum – headache, sinus pressure, sneezing,* Mercurius Iodatus Ruber – runny nose,* Spongia Tosta – runny nose,* Thuja Occidentalis – runny nose, sneezing,* Antimonium Tartaricum – sinus pressure, congestion*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Uses:

May help temporarily relieve

■ sinus symptoms ■ sinus headache ■ nasal congestion ■ sinus pressure ■ sneezing*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Stop use and ask a doctor if

■ symptoms worsen or persist for more than 5 days

■ new symptoms appear

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is missing or open.

■ Store at room temperature (65-80°F)

Keep Out Of Reach Of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children 12 years and older: ■ take 15 drops under the tongue every hour for 4 hours, then reduce to every 4 hours or as needed.

Inactive Ingredients:

20% alcohol, purified water

Questions:

Dist. By NaturalCare

201 Apple Blvd.

Woodbine, IA 51579

www.NaturalCareWorks.com

1-888-280-5672

Package Label Display:

NaturalCare

SinuFix

Homeopathic

1 FL OZ (30 mL)

* Please review the disclaimer below.