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| Product NDC Code | 0116-0181 | ||||
|---|---|---|---|---|---|
| Drug Name | Betadine |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M022 | ||||
| Labeler Name | Xttrium Laboratories, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Povidone-iodine, 0.5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions DO NOT SWAllOW Adults and children 12 years and older : ■ Gargle with 10 ml full strength for 30 seconds, then spit out ■ Use only with dosing cup provided ■ Use up to 4 times daily Children under 12 : Do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients citric acid, flavor, glycenn, propylene glycol, puritied water, saccharin sodium, sodium hydroxide.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.For the temporary relief of occasional sore throat
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic
Spl product data elements
Usually a list of ingredients in a drug product.Betadine Povidone Iodine SACCHARIN SODIUM SODIUM HYDROXIDE POVIDONE-IODINE IODINE GLYCERIN PROPYLENE GLYCOL ANHYDROUS CITRIC ACID WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Betadine Gargle 8oz Betadine Gargle Shelf Carton
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case more than used for gargling is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information ■ store at 25°F (77°F); excursions permitted between 15°-30°C (59°-86°F) ■ may stain clothing or dental work ■ avoid contact with jewelry, especially silver
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-833-288-2684
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warning Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to 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 othe ringredients in this product ■ if you have any thyroid condtions When using this product ■ do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor ■ do not swallow ■ do not use with hydrogen peroxide Stop use and ask a doctor ■ 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API