FDA.reportPublic FDA data

Mucus-Clear Sinus Relief

Manufacturer
Silver Star Brands | Vitality Works
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:59

Label at a glance#

ProductMucus-Clear Sinus Relief
Active ingredientATROPA BELLADONNA, SANGUINARIA CANADENSIS ROOT, CALCIUM SULFIDE, PULSATILLA PATENS WHOLE, SPIGELIA ANTHELMIA, POTASSIUM DICHROMATE
Label structure10 sections

Indications and uses

Uses*: Homeopathic remedy for sinus headache relief. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Directions: Adults & Children 2+: mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat every 2 hours until symptoms subside.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Equal volues of each ingredient: Belladonna 6C, Hepar sulph calc 6C, Kali bic 6C, Pulsatilla 6C, Sanguinaria 6C, Spigelia Anth 6C.

Uses*:

INDICATIONS & USAGE SECTION

Uses*: Homeopathic remedy for sinus headache relief.

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

Warnings:

WARNINGS SECTION

Warnings: If symptoms persist or worsen, consulta healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Adults & Children 2+: mix 0.50 mL in 1/4 cup of water and sip slowly. Repeat every 2 hours until symptoms subside.

OTHER SAFETY INFORMATION

Contains no artificial flavors or colorants. No gluten added.

Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified water, USP grain alcohol (20% by volume).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Relieves sinus congestion, pain & headache.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MC Sinus Relief imgMC Sinus Relief img

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-370-592023-12-26C16284748780-1f386c64a-1e4d-0266-e053-dadaa90a7c1aNativeRemedies® Mucus-Clear™ Sinus Relief
68703-370-592023-01-30C16284748780-1f386c64a-1e4d-0266-e053-dadaa90a7c1aNativeRemedies® Mucus-Clear™ Sinus Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-370-59Mucus-Clear Sinus Relief59 mL in 1 BOTTLE, GLASSLIQUID593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-370MUCUS-CLEAR SINUS RELIEF (BELLADONNA, HEPAR SULPH CALC, KALI BIC, PULSATILLA, SANGUINARIA, SPIGELIA ANTH) LIQUID [SILVER STAR BRANDS]3Current NDC, Legacy NDC, 1 package rows20250103_c4459a80-3de7-504a-e053-2a95a90a337a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-37068703-370-59

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
PULSATILLA PATENS WHOLE4M1169RWJDACTIB
SPIGELIA ANTHELMIAWYT05213GEACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
POTASSIUM DICHROMATET4423S18FMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucus-Clear Sinus ReliefBELLADONNA, HEPAR SULPH CALC, KALI BIC, PULSATILLA, SANGUINARIA, SPIGELIA ANTHSilver Star Brandsc4459a80-3de7-504a-e053-2a95a90a337a2025-01-01WarningsExact identifier
ndc (package): 68703-370-59
ndc (product): 68703-370
ndc11 (package): 68703037059
spl id: 2ab0efa0-68e3-1b30-e063-6294a90ae73e
spl set id: c4459a80-3de7-504a-e053-2a95a90a337a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.