THYROSAFE- potassium iodide tablet 
Recipharm AB (publ)

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Drug Facts

Active Ingredient (in each tablet)

Potassium Iodide 65 mg

Purpose

Thyroid blocking

Use helps prevent radioactive iodine from getting into the thyroid gland during a nuclear radiation emergency.

Use along with other emergency measures recommended by public officials.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

Inactive ingredients

lactose, magnesium stearate, microcrystalline cellulose

Questions or comments?

call toll free 1-866-849-7672

Principal Display Panel - 65 mg Carton Label

NDC-66983-350-20

ThyroSafe®

Potassium Iodide Tablets, USP, 65 mg

Thyroid blocking in a radiation emergency only

20 tablets, 65 milligrams each

Recipharm

Principal Display Panel - 65 mg Carton Label
THYROSAFE 
potassium iodide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66983-350
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Potassium Iodide (UNII: 1C4QK22F9J) (Iodide Ion - UNII:09G4I6V86Q) Potassium Iodide65 mg
Inactive Ingredients
Ingredient NameStrength
Lactose, Unspecified form (UNII: J2B2A4N98G)  
Microcrystalline Cellulose (UNII: OP1R32D61U)  
Magnesium Stearate (UNII: 70097M6I30)  
Product Characteristics
Colorwhite (white) Score4 pieces
ShapeROUND (ROUND) Size9mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66983-350-20160 in 1 CARTON09/30/2002
120 in 1 BOX
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07635009/30/2002
Labeler - Recipharm AB (publ) (508619434)
Establishment
NameAddressID/FEIBusiness Operations
Recipharm Fontaine260428962MANUFACTURE(66983-350)

Revised: 11/2021
Document Id: 7a03a65b-330b-4d71-a445-c66eda195a03
Set id: 4f577f7a-4390-488c-b327-13a32e06be04
Version: 3
Effective Time: 20211130
 
Recipharm AB (publ)