Otc - Purpose
Relieves sinus congestion, pain and headache
Sinus Soothe
FDA Label NDC 68703-093
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Native Remedies, Llc for the product Sinus Soothe (NDC 68703-093). 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 otc - purpose, otc - active ingredient, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients: Each dose contains equal parts of: Kali bich 6C HPUS, Pulsatilla 6C HPUS, Hepar sulph 6C HPUS, Thuja occ, Spigelia anth 6C HPUS
Indications & Usage
Uses: Homeopathic remedy to relieve the symptoms of sinusitis
Warnings
Warnings: If symptoms persist or worsen, consult a healthcare professional
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of reach of children
Overdosage
In case of overdose, get medical help or contact Poison Control Center right away
Dosage & Administration
Directions:For all ages: Mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat every 2 hours until symptoms subside
Inactive Ingredient
Inactive Ingredients: USP Purified water, grain alcohol (20% by volume)
Information For Patients
The letters HPUS indicate that the component in this product are oficically monographed in the Homeopathic Pharmacopoeia of the United States
All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Suite 160
Boca Raton, FL 33487
Phone:+1.877.289.1235
International:+1.561.999.8857
Contains no animal products, gluten, artificial flavors, preservatives or colorants. Suitable for vegetarians and safe for all ages
Storage And Handling
Tamper resistant for you protection. Use only if safety seal is intact
Package Label.Principal Display Panel
Bottle Label (Sso001)
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