Betadine Gargle POVIDONE IODINE ATLANTIS CONSUMER HEALTHCARE, INC. FDA Approved Uses For the temporary relief of occasional sore throat
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Substance Povidone Iodine
Route
ORAL
Applications
M022

Drug Facts

Composition & Profile

Active Ingredients
Drug Facts Active ingredient Povidone-iodine 0.5%(0.05% available iodine)
Inactive Ingredients
Inactive ingredients citric acid flavor glycerin propylene glycol purified water saccharin sodium sodium hydroxide
Strengths
0.05 %
Treats Conditions
Uses For The Temporary Relief Of Occasional Sore Throat

Identifiers & Packaging

Container Type BOX
UNII
85H0HZU99M
Packaging

BetadineGargle Carton NDC: 67618-181-08 Betadine Gargle Carton

Package Descriptions
  • BetadineGargle Carton NDC: 67618-181-08 Betadine Gargle Carton

Overview

Uses For the temporary relief of occasional sore throat

Indications & Usage

Uses For the temporary relief of occasional sore throat

Dosage & Administration

Directions 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.

Warnings & Precautions
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
Purpose

Purpose Antiseptic Uses For the temporary relief of occasional sore throat

Do Not Use

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

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 & Ask a Doctor

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

Keep Out of Reach of Children

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.

Storage & Handling

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


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