SINUSIN - 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

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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DOSAGE FORM

Oral liquid in vials.

CONTRAINDICATIONS

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

PRECAUTIONS

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

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

DRUG ABUSE AND DEPENDENCE

Not applicable for homeopathic drugs.



OVERDOSAGE

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

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

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

STORAGE CONDITION

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

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 gently flicking or tapping top of the vial with fingers as in Step (1).  

OV Image 1.jpg

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

OV 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.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.jpg

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

OV Image 5.jpg

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 Slowly release pressure on the bulb of the pipette until solution is withdrawn from vial (6).

OV Image 6.jpg

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 Remove pipette when the solution has been withdrawn (7).

OV Image 7.jpg

Administer according to carton insert. Discard unused portion.



BE CAREFUL OF SHARP EDGES AFTER OPENING VIAL.


Sinusin OV label.jpg

Sinusin OV label.jpg

SINUSIN 
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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51885-3150
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS2 [hp_X]  in 2.2 mL
EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K) EUPHORBIA RESINIFERA RESIN4 [hp_X]  in 2.2 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU) LUFFA OPERCULATA FRUIT6 [hp_X]  in 2.2 mL
MERCURIC IODIDE (UNII: R03O05RB0P) (MERCURIC IODIDE - UNII:R03O05RB0P) MERCURIC IODIDE8 [hp_X]  in 2.2 mL
SUS SCROFA NASAL MUCOSA (UNII: ID3Z1X61WY) (SUS SCROFA NASAL MUCOSA - UNII:ID3Z1X61WY) SUS SCROFA NASAL MUCOSA8 [hp_X]  in 2.2 mL
SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE10 [hp_X]  in 2.2 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (SULFATE ION - UNII:7IS9N8KPMG) CALCIUM SULFIDE10 [hp_X]  in 2.2 mL
SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5) SINUSITISINUM13 [hp_X]  in 2.2 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51885-3150-12.2 mL in 1 VIAL, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2011
Labeler - Biologische Heilmittel Heel (315635359)

Revised: 8/2010
Document Id: b8dd861c-013d-45bc-8db1-f10305a7acb5
Set id: 9243cf32-4759-47d1-8191-93d49419653e
Version: 1
Effective Time: 20100806
 
Biologische Heilmittel Heel