SinuClean description, usages, side effects, indications, overdosage, supplying and lots more!

SinuClean

Galsor S.r.l

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert



FULL PRESCRIBING INFORMATION

Active ingredient

Ecballium Elaterium extract

Purpose

PURPOSE

Helps expel mucus from the paranasal sinuses.

Helps reduce symptoms of sinusitis (headache, facial pain, heavy head, nasal obstruction, malaise).

USES

  • Reduces intensity and duration of sinusitis symptoms.
  • Helps expel mucus from the paranasal sinuses.
  • Facilitates recovery sinusitis attack.

WARNING

Stop use and ask a doctor in case symptoms persist and are accompanied by fever.

Contains no antibacterial, anti-allergic or anti-flu activity.

If you are pregnant or breast-feeding, consult a doctor before use.

Do not use in children under 6 years old.

Keep out of reach of children.

Do not use if you are allergic to one of the ingredients or the product.

DIRECTIONS

In erect position, gently insert the nozzle into each nostril, the spray 2 to 3 puffs. Repeat 2 times/day, for 3-6 days. In case of excessive sneezing after the first spray puff, repeat the treatment after 15 minutes, as the product could have been wiped away mechanically by the sneezing.,

Do not expose the product to the light or heat. Take care to close the bottle after the use.

Purified Water, Eucalyptol, Mint Aroma, Methylparaben, Propylparaben

This section contains images of the bottle and carton labels.

This is the bottle label.

This is the carton label.


SinuClean

ECBALLIUM ELATERIUM SOLUTION SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:47784-001
Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Ecballium Elaterium Fruit ECBALLIUM ELATERIUM FRUIT 22.09 mL

Inactive Ingredients

Ingredient Name Strength
water
EUCALYPTOL
METHYLPARABEN
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BOTTLE, SPRAY
2 NDC:47784-001-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-10-22


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Be sure to consult your doctor before taking any medication!
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