Label: THYROSAFE- potassium iodide tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 66983-350-20 - Packager: Recipharm AB (publ)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 30, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each tablet)
- Purpose
- INDICATIONS & USAGE
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Warnings
Allergy alert: Iodine may cause an allergic reaction with 1 or more of the following symptoms:
- shortness of breath or wheezing
- swelling
- skin rash
- trouble breathing, speaking or swallowing
- fever and joint pain
Do not use if you have
- ever had an allergic reaction to iodine
- nodular thyroid disease with heart disease
- hypocomplementemic vasculitis
- dermatitis herpetiformis
Stop use and ask a doctor if you have
- allergic reaction. Get medical help right away if you have trouble breathing, speaking or swallowing; shortness of breath; wheezing; swelling of the mouth, tongue or throat; or rash.
- irregular heart or chest pain. Get medical help right away.
- swelling of the hands or feet, fever, or joint pain
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Directions
- use as directed by public officials in the event of a nuclear radiation emergency
- do not take more than 1 dose in 24 hours
- tablets can be whole or crushed and mixed in milk, baby formula, water, orange juice, flat soda like cola, or raspberry syrup. The liquid mixture should be given to infants, young children, and others who cannot swallow tablets; see consumer package insert on how to make a liquid mixture.
adults over 18 years 2 tablets (whole or crushed) daily (130 mg) children over 12 years to 18 years who weigh at least 150 pounds 2 tablets (whole or crushed) daily (130 mg) children over 12 years to 18 years who weigh less than 150 pounds 1 tablet (whole or crushed) daily (65 mg) children over 3 years to 12 years 1 tablet (whole or crushed) daily (65 mg) children over 1 month to 3 years 1/2 tablet (crushed) daily (32.5 mg) babies at birth to 1 month 16.25 mg daily as directed in consumer package insert - PREGNANCY OR BREAST FEEDING
- Other information
- Inactive ingredients
- Questions or comments?
- Principal Display Panel - 65 mg Carton Label
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INGREDIENTS AND APPEARANCE
THYROSAFE
potassium iodide tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66983-350 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Potassium Iodide 65 mg Inactive Ingredients Ingredient Name Strength Lactose, Unspecified form (UNII: J2B2A4N98G) Microcrystalline Cellulose (UNII: OP1R32D61U) Magnesium Stearate (UNII: 70097M6I30) Product Characteristics Color white (white) Score 4 pieces Shape ROUND (ROUND) Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66983-350-20 160 in 1 CARTON 09/30/2002 1 20 in 1 BOX 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076350 09/30/2002 Labeler - Recipharm AB (publ) (508619434) Establishment Name Address ID/FEI Business Operations Recipharm Fontaine 260428962 MANUFACTURE(66983-350)
