Sinusin

Manufacturer
Biologische Heilmittel Heel
Effective date
2010-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:02:45

Label at a glance#

ProductSinusin
Active ingredientPULSATILLA VULGARIS, EUPHORBIA RESINIFERA RESIN, LUFFA OPERCULATA FRUIT, MERCURIC IODIDE, SUS SCROFA NASAL MUCOSA, SILVER NITRATE, CALCIUM SULFIDE, SINUSITISINUM
Label structure11 sections

Dosage and administration

Adults and children above 6 years: In general 1 vial 1-3 times daily Children to 6 years: 1/2 the adult dosage Administration: NOT FOR INJECTION - FOR ORAL ADMINISTRATION ONLY. Instructions for Opening Vial 1. Vials are pre-scored for easy opening and are marled with a color dot above the neck of the vial. The use of a file is not required. First, ensure that all contents of the vial are below the narrow neck by g...

Storage and handling

Avoid freezing and excessive heat. Store at room temperature. Protect from direct light.

Label contents#

Full prescribing information#

DOSAGE FORM

DOSAGE FORMS & STRENGTHS SECTION

Oral liquid in vials.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

This drug is contriandicated in patients with a known hypersensitivity to any of its ingredients.

PRECAUTIONS

PRECAUTIONS SECTION

Pregnancy and nursing mothers: Pregnancy Category C. In general, homeopathic drugs are not known to cause direct or indirect harm to the fetus. However, animal reproduction studies have not been performed and there are no well-controlled studies in pregnant women. In cases of pregnancy or suspected pregnancy, a physician should be consulted before administering this drug. It is not known whether any of the ingredients are excreted in human milk. However because many drugs are excreted in human milk, homeopathic drugs should be administered with caution to nursing mothers.


Pediatric use: Homeopathic drugs can be safely administered to children. See Dosage and Administration.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

In rare cases, patients with a hypersensitivity to any of the ingredients may experience an allergic reaction after oral administration.

DRUG ABUSE AND DEPENDENCE

DRUG ABUSE AND DEPENDENCE SECTION

Not applicable for homeopathic drugs.


OVERDOSAGE

OVERDOSAGE SECTION

Due to the low concentration of active ingredients, adverse reactions following overdosage are extremely rare. Care must be taken not to exceed the recommended dosage.

WARNINGS

WARNINGS SECTION

If symptoms persist for more than a few days, a physician should be consulted.

Keep this and all medicines out of the reach of children.

HOW SUPPLIED

HOW SUPPLIED SECTION

Heel vials are supplied in sizes of 1.1ml, 2.0ml and 2.2ml. See carton label for content information.

STORAGE CONDITION

STORAGE AND HANDLING SECTION

Avoid freezing and excessive heat. Store at room temperature. Protect from direct light.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children above 6 years: In general 1 vial 1-3 times daily

Children to 6 years: 1/2 the adult dosage

Administration: NOT FOR INJECTION - FOR ORAL ADMINISTRATION ONLY.

Instructions for Opening Vial

1. Vials are pre-scored for easy opening and are marled with a color dot above the neck of the vial. The use of a file is not required. First, ensure that all contents of the vial are below the narrow neck by gently flicking or tapping top of the vial with fingers as in Step (1).  

OV Image 1.jpgOV Image 1.jpg

2. Hold vial firmly with one hand with dot toward you (2).

OV Image 2.jpgOV Image 2.jpg

3. With the other hand, snap the vial top slightly upward and away from dot (3). Discard the vial top and be careful of sharp glass edges.

OV Image 3.jpgOV Image 3.jpg

4. To withdraw solution: Tilt open vial until it is nearly horizontal (The vial should be tilted as far as possible without spilling the contents.) (4).

OV Image 4.jpgOV Image 4.jpg

5. Squeeze bulb of the pipette and insert pipette tip into the solution (5).

OV Image 5.jpgOV Image 5.jpg

6. Slowly release pressure on the bulb of the pipette until solution is withdrawn from vial (6).

OV Image 6.jpgOV Image 6.jpg

7. Remove pipette when the solution has been withdrawn (7).

OV Image 7.jpgOV Image 7.jpg

Administer according to carton insert. Discard unused portion.


BE CAREFUL OF SHARP EDGES AFTER OPENING VIAL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Sinusin OV label.jpgSinusin OV label.jpg

Sinusin OV label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51885-3150-12019-10-21C16284748780-1956f9ecf-d86f-621f-e053-dbdaa90a74ad9243cf32-4759-47d1-8191-93d49419653e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51885-3150-1Sinusin2.2 mL in 1 VIAL, GLASSSOLUTION2.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51885-3150SINUSIN (PULSATILLA VULGARIS AND EUPHORBIA RESINIFERA RESIN AND LUFFA OPSILVER NITRATEERCULATA FRUIT AND MERCURIC IODIDE AND SUS SCROFA NASAL MUCOSA AND SILVER NITRATE AND CALCIUM SULFIDE AND SINUSITISINUM) SOLUTION [BIOLOGISCHE HEILMITTEL HEEL]1Legacy NDC, 1 package rows20110101_9243cf32-4759-47d1-8191-93d49419653e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALCIUM SULFIDEACTIVE INGREDIENT1MBW07J51Q1
EUPHORBIA RESINIFERA RESINACTIVE INGREDIENT1TI1O9028K1
LUFFA OPERCULATA FRUITACTIVE INGREDIENTC4MO6809HU1
MERCURIC IODIDEACTIVE INGREDIENTR03O05RB0P1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SILVER NITRATEACTIVE INGREDIENT95IT3W8JZE1
SINUSITISINUMACTIVE INGREDIENTB575563DM51
SUS SCROFA NASAL MUCOSAACTIVE INGREDIENTID3Z1X61WY1
EUPHORBIA RESINIFERA RESINACTIVE MOIETY1TI1O9028K1
LUFFA OPERCULATA FRUITACTIVE MOIETYC4MO6809HU1
MERCURIC IODIDEACTIVE MOIETYR03O05RB0P1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SILVER CATIONACTIVE MOIETY57N7B0K90A1
SINUSITISINUMACTIVE MOIETYB575563DM51
SULFATE IONACTIVE MOIETY7IS9N8KPMG1
SUS SCROFA NASAL MUCOSAACTIVE MOIETYID3Z1X61WY1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51885-315051885-3150-1

Ingredients#

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

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

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
b8dd861c-013d-45bc-8db1-f10305a7acb59243cf32-4759-47d1-8191-93d49419653e2010-08-06Warnings, Adverse reactionsExact identifier
spl id: b8dd861c-013d-45bc-8db1-f10305a7acb5
spl set id: 9243cf32-4759-47d1-8191-93d49419653e

Reported adverse events (FAERS/openFDA)#

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