GOODYS HEADACHE RELIEF SHOT (ACETAMINOPHEN AND CAFFEINE) LIQUID [MEDTECH PRODUCTS INC.]

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  • GOODYS HEADACHE RELIEF SHOT (ACETAMINOPHEN AND CAFFEINE) LIQUID [MEDTECH PRODUCTS INC.]

GOODYS HEADACHE RELIEF SHOT (ACETAMINOPHEN AND CAFFEINE) LIQUID [MEDTECH PRODUCTS INC.]
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NDC 63029-629-01, 63029-639-01
Set ID 374df462-aff6-4642-ba6f-e83a278fadcf
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number PART343
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 GoodysHeadacheReliefShot.com

  • PRINCIPAL DISPLAY PANEL

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

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

  • PRINCIPAL DISPLAY PANEL

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

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

  • PRINCIPAL DISPLAY PANEL

    NDC- 63029-629-02
    Goody’s Headache Relief Shot
    Single Dose

    PRINCIPAL DISPLAY PANEL NDC- 63029-629-02 Goody’s Headache Relief Shot Single Dose

  • INGREDIENTS AND APPEARANCE
    GOODYS HEADACHE RELIEF SHOT 
    acetaminophen and caffeine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-639
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 60 mL
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K30 (UNII: U725QWY32X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorCITRUSImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-639-012 in 1 DOSE PACK02/11/201306/30/2023
    160 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:63029-639-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product02/11/201306/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34302/11/201306/30/2023
    GOODYS HEADACHE RELIEF SHOT 
    acetaminophen and caffeine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-629
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN1000 mg  in 60 mL
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-629-012 in 1 DOSE PACK02/11/2013
    160 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
    2NDC:63029-629-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product02/11/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34302/11/2013
    Labeler - Medtech Products Inc. (122715688)
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