FDA Label for Sinusin
View Indications, Usage & Precautions
Sinusin Product Label
The following document was submitted to the FDA by the labeler of this product Biologische Heilmittel Heel. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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).
2. Hold vial firmly with one hand with dot toward you (2).
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.
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).
5. Squeeze bulb of the pipette and insert pipette tip into the solution (5).
6. Slowly release pressure on the bulb of the pipette until solution is withdrawn from vial (6).
7. Remove pipette when the solution has been withdrawn (7).
Administer according to carton insert. Discard unused portion.
BE CAREFUL OF SHARP EDGES AFTER OPENING VIAL.
Package Label.Principal Display Panel
Sinusin OV label.jpg
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