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FDA LABEL GENERIC: Povidone-iodine MFR: Atlantis Consumer Healthcare, Inc.

Betadine 0.5 % Mouthwash

Active ingredient

Povidone-iodine, 0.5%(0.05% available iodine)

Antiseptic

INDICATIONS AND USAGE

For the temporary relief of occasional sore throat

WARNINGS

SoreThroat Warning: Severe or persistent sore throat or sore throataccompanied by high fever, headache, nausea, and vomiting may be serious.Consult doctor promptly. Do not use more than 2 days or administerto children under 3 years of age unless directed by a doctor.

Do not use this product

for more than 7 days unless directed by a dentist or doctor if you are allergic to povidone-iodine or any other ingredientsin this product if you have any thyroid conditions

When using this product

do not get into eyes. If contact occurs, rinse eyes thoroughlywith water. If irritation persists, consult a doctor do not swallow do not use with hydrogen peroxide

Stop use and ask a doctor if

symptoms do not improve in 7 days irritation, pain, or redness persists or worsens swelling, rash, or fever develops
If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case more than used for gargling is accidentally swallowed, getmedical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

DO NOT SWALLOW
Adults andchildren 12 years and older:

Gargle with 10 ml full strength for 30 seconds, then spitout Use only with dosing cup provided Use up to 4 times daily Children under 12: Do not use.

store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C(59⁰-86⁰F) may stain clothing or dental work avoid contact with jewelry, especially silver
citric acid,flavor, glycerin, propylene glycol, purified water, saccharin sodium,sodium hydroxide

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431
305586-0E

ASK A DOCTOR

BetadineGargle Carton
NDC: 67618-181-08