GOODYS EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]

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GOODYS EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]
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NDC 63029-633-01, 63029-644-01, 63029-655-01, 63029-662-01, 63029-677-01
Set ID 16d774cc-4247-4bf8-9b5a-c338ffebda3d
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

    FAST PAIN RELIEF
    Goody’s®
    EXTRA STRENGTH
    HEADACHE POWDERS

    ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
    PAIN RELIEVER / PAIN RELIEVER AID
    24 ENVELOPES CONTAINING 6 POWDERS EACH

    Drug Facts

  • Active ingredients

    (in each powder):
    Acetaminophen 260 mg
    Aspirin (NSAID*) 520 mg
    Caffeine 32.5 mg
    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever/fever reducer
    Pain reliever/fever reducer
    Pain reliever aid

  • Uses

    • temporarily relieves minor aches and pains due to:

    • headache
    • minor arthritis pain     		• muscle aches
    • colds

    • temporarily reduces fever

  • Warnings:

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy Alert: Aspirin may cause severe allergic reaction which may include:
    • hives • facial swelling • shock • asthma (wheezing).

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

    • more than 4 powders 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

    Stomach bleeding warning: This product contains a NSAID, which may cause severe stomach
    bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed.

    Do not use

    • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if

    • you have liver disease
    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have asthma

    Ask a doctor or pharmacist before use if you are

    taking a prescription drug for diabetes, gout, or arthritis

    When using this product

    limit the use of caffeine-containing drugs, food, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following sights of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • any new symptoms appear
    • ringing in the ears or a loss of hearing occurs
      These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children.

  • Overdose warning:

    Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children 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 and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or stir powder into a glass of water or other liquid.
    • do not take more than 4 powders in 24 hours unless directed by a doctor.
    • children under 12 years of age: ask a doctor.
  • Other information

    • each powder contains: potassium 60 mg
    • store below 25°C (77°F)
  • Inactive ingredients

    lactose monohydrate, potassium chloride

  • Questions or comments?

    1-866-255-5197 (English/Spanish) weekdays

  • PRINCIPAL DISPLAY PANEL

    FAST PAIN RELIEF
    Goody’s®
    EXTRA STRENGTH
    HEADACHE POWDERS
    ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
    PAIN RELIEVER / PAIN RELIEVER AID
    24 ENVELOPES CONTAINING 6 POWDERS EACH

    FAST PAIN RELIEF Goody’s® EXTRA STRENGTH HEADACHE POWDERS ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID 24 ENVELOPES CONTAINING 6 POWDERS EACH

  • PRINCIPAL DISPLAY PANEL

    FAST PAIN RELIEF
    Goody’s®
    EXTRA STRENGTH
    HEADACHE POWDERS
    ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
    PAIN RELIEVER / PAIN RELIEVER AID
    18 Powders

    FAST PAIN RELIEF Goody’s® EXTRA STRENGTH HEADACHE POWDERS ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID 18 Powders

  • PRINCIPAL DISPLAY PANEL

    FAST PAIN RELIEF
    Goody’s®
    EXTRA STRENGTH
    HEADACHE POWDERS
    ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
    PAIN RELIEVER / PAIN RELIEVER AID
    24 Powders

    FAST PAIN RELIEF Goody’s® EXTRA STRENGTH HEADACHE POWDERS ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID 24 Powders

  • PRINCIPAL DISPLAY PANEL

    FAST PAIN RELIEF
    Goody’s®
    EXTRA STRENGTH
    HEADACHE POWDERS
    ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
    PAIN RELIEVER / PAIN RELIEVER AID
    50 Powders

    FAST PAIN RELIEF Goody’s® EXTRA STRENGTH HEADACHE POWDERS ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID 50 Powders

  • INGREDIENTS AND APPEARANCE
    GOODYS EXTRA STRENGTH 
    acetaminophen, aspirin, and caffeine powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-662
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM (UNII: RWP5GA015D)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-662-016 in 1 BOX; Type 0: Not a Combination Product11/01/201311/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34311/01/201311/30/2023
    GOODYS EXTRA STRENGTH 
    acetaminophen, aspirin, and caffeine powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-655
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM (UNII: RWP5GA015D)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-655-0118 in 1 BOX; Type 0: Not a Combination Product11/01/201311/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34311/01/201311/30/2023
    GOODYS EXTRA STRENGTH 
    acetaminophen, aspirin, and caffeine powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-633
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM (UNII: RWP5GA015D)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-633-0124 in 1 BOX; Type 0: Not a Combination Product11/01/201311/30/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34311/01/201311/30/2023
    GOODYS EXTRA STRENGTH 
    acetaminophen, aspirin, and caffeine powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-644
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM (UNII: RWP5GA015D)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-644-0150 in 1 BOX; Type 0: Not a Combination Product11/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34311/01/2013
    Labeler - Medtech Products Inc. (122715688)
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