BETADINE SORE THROAT GARGLE povidone-iodine 75mg/mL mouthwash bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

povidone-iodine, Quantity: 75 mg/mL (Equivalent: iodine, Qty 7.5 mg/mL)

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Pharmaceutical form:

Mouthwash

Composition:

Excipient Ingredients: citric acid monohydrate; ethanol; glycerol; dibasic sodium phosphate dodecahydrate; methyl salicylate; sodium hydroxide; menthol; purified water

Administration route:

Oral Application

Units in package:

40mL, 15mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Antibacterial for use as an aid in the treatment of sore throats.

Product summary:

Visual Identification: A brown solution; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-25

Patient Information leaflet

BETADINE SORE THROAT GARGLE
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ACTIVE INGREDIENT: _povidone iodine_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Betadine Sore Throat Gargle. YOU SHOULD ALSO SPEAK
TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER
INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS
ABOUT USING BETADINE SORE THROAT GARGLE.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Betadine Sore Throat Gargle?
2. What should I know before I use Betadine Sore Throat?
3. What if I am taking other medicines?
4. How do I use Betadine Sore Throat Gargle?
5. What should I know while using Betadine Sore Throat
Gargle?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING BETADINE SORE THROAT
GARGLE?
BETADINE SORE THROAT GARGLE CONTAINS THE ACTIVE
INGREDIENT POVIDONE-IODINE.
BETADINE SORE THROAT GARGLE IS A CONCENTRATED ANTI#
BACTERIAL FORMULA USED AS AN AID IN THE TREATMENT OF SORE
THROATS.
IT CONTAINS ALCOHOL (30.5% W/V.)
2.
WHAT SHOULD I KNOW BEFORE I USE BETADINE
SORE THROAT?
WARNINGS
BETADINE SORE THROAT GARGLE MUST NOT BE
SWALLOWED.
DO NOT USE BETADINE SORE THROAT GARGLE IF:
•
you are allergic to povidone or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use
this medicine.
•
you have a severe sore throat accompanied by fever,
headache, nausea or vomiting or any sore throat
persisting for more than 2 days may be serious. In such
cases consult a doctor.
•
you have a known hypersensitivity to povidone iodine,
iodine, polyvinylpyrrolidone or to any excipient. If
irritation, redness or swelling develops, discontinue
treatment and consult a doctor.
•
you have a known to have thyroid disease including
goiter, thyroid nodules, or other thyroid diseases
(especially elderly patients) as there may be a risk of
developing hyperthyroidism from the administration of
large amounts of iodine.
•
The maximum treatment duration of 14 days should
not be exceeded. Pr