Label: GOODYS HEADACHE RELIEF SHOT- acetaminophen and caffeine liquid 

  • Label RSS
  • NDC Code(s): 63029-629-01, 63029-639-01
  • Packager: Medtech Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    (per 60 mL)

    Acetaminophen 1000 mg

    Caffeine 65 mg

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  • Purpose

    Pain reliever/ Pain Reliever Aid

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  • Use

    Temporarily relieves minor aches and pains due to:

    •       headache

    •       sore throat

    •       minor arthritis pain

    •       muscle aches

    •       cold and flu

    •       toothache

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  • 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.      

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  • 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      

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  • Other information

    •       store at room temperature

    •       read all product information before using      

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  • Inactive ingredients

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

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  • Questions?

    1-866-255-5197 GoodysHeadacheReliefShot.com

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  • PRINCIPAL DISPLAY PANEL

    NDC- 63029-639-01
    Goody’s Headache Relief Shot
    2 Pack
    Berry

    NDC- 63029-639-01
Goody’s Headache Relief Shot
2 Pack 
Berry

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  • PRINCIPAL DISPLAY PANEL

    NDC- 63029-629-01
    Goody’s Headache Relief Shot
    2 Pack
    Citrus

    NDC- 63029-629-01
Goody’s Headache Relief Shot
2 Pack 
Citrus

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  • INGREDIENTS AND APPEARANCE
    GOODYS HEADACHE RELIEF SHOT 
    acetaminophen and caffeine liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63029-639
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 1000 mg  in 60 mL
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg  in 60 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    GLYCERIN  
    POTASSIUM CITRATE  
    POTASSIUM SORBATE  
    PROPYLENE GLYCOL  
    WATER  
    SUCRALOSE  
    POVIDONE K29/32  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor CITRUS Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-639-01 2 in 1 DOSE PACK
    1 60 mL in 1 BOTTLE, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 02/11/2013
    GOODYS HEADACHE RELIEF SHOT 
    acetaminophen and caffeine liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63029-629
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 1000 mg  in 60 mL
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg  in 60 mL
    Inactive Ingredients
    Ingredient Name Strength
    ANHYDROUS CITRIC ACID  
    GLYCERIN  
    POTASSIUM CITRATE  
    POTASSIUM SORBATE  
    PROPYLENE GLYCOL  
    WATER  
    SUCRALOSE  
    POVIDONE K29/32  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor BERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-629-01 2 in 1 DOSE PACK
    1 60 mL in 1 BOTTLE, UNIT-DOSE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part343 02/11/2013
    Labeler - Medtech Products Inc. (122715688)
    Establishment
    Name Address ID/FEI Business Operations
    Fareva Richmond, Inc. 969523245 MANUFACTURE(63029-639, 63029-629)
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