FDA Label for Goodys Headache Relief Shot

View Indications, Usage & Precautions

Goodys Headache Relief Shot Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



(per 60 mL)

Acetaminophen 1000 mg

Caffeine 65 mg


Purpose



Pain reliever/ Pain Reliever Aid


Use



Temporarily relieves minor aches and pains due to:

  • headache
  • sore throat
  • minor arthritis pain
  • muscle aches
  • cold and flu
  • toothache

Warnings



Liver warning: This product contains acetaminophen. Severe liver damage may occur if

you take

  • more than 4 Headache Relief Shots™ in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
  • Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Caffeine warning: This product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.


Do Not Use



  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product      

Ask A Doctor Before Use If



you have liver disease.      


Ask A Doctor Or Pharmacist Before Use If



you are taking the blood thinning drug warfarin.      


Stop Use And Ask A Doctor If



  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present       

If Pregnant Or Breastfeeding,



ask a healthcare professional before use.


Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.      


Directions



  • do not take more than directed (see overdose warning)
  • adults and children 12 years of age and over: take one Headache Relief Shot every 6 hours while symptoms persist; do not take more than 4 Headache Relief Shots in 24 hours.
  • children under 12 years of age: ask a doctor      

Other Information



  • store at room temperature
  • read all product information before using      

Inactive Ingredients



citric acid, flavor, glycerin, polyvinylpyrrolidone, potassium citrate, potassium sorbate, propylene glycol, purified water, sucralose      


Questions?



1-866-255-5197 GoodysPowder.com


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