BETADINE® Sore Throat Gargle0.5% Povidone-iodine

Drug Facts

Active ingredient

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

Purpose

Antiseptic

Uses

• 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.

Directions

DO NOT SWALLOWAdults andchildren 12 years and older:

Children under 12: Do not use.

• Gargle with 10 ml full strength for 30 seconds, then spitout
• Use only with dosing cup provided
• Use up to 4 times daily

Other information

• store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C(59⁰-86⁰F)
• may stain clothing or dental work
• avoid contact with jewelry, especially silver

Inactive ingredients

citric acid,flavor, glycerin, propylene glycol, purified water, saccharin sodium,sodium hydroxide

Dist. by: Avrio Health L.P.Stamford, CT 06901-3431305586-0E

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BetadineGargle CartonNDC: 67618-181-08