GOODYS PM PAIN RELIEVER (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]

GOODYS PM PAIN RELIEVER (ACETAMINOPHEN AND ASPIRIN AND CAFFEINE) CAPSULE, COATED [MEDTECH PRODUCTS INC.]
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NDC 63029-062-10, 63029-062-24
Set ID 8d4fc971-492d-471d-a3c2-7d8e2237a5f3
Category HUMAN OTC DRUG LABEL
Packager Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number PART343
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    (in each caplet)

    Acetaminophen 250 mg

    Aspirin (NSAID**) 250 mg

    **nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever

  • Active ingredient

    (in each caplet)

    Caffeine 65 mg

  • Purpose

    Pain reliever aid

  • Uses

    temporarily relieves minor aches and pains due to

    • headache
    • minor arthritis pain
    • muscle aches
    • colds
  • 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 a 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 8 caplets 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 an 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

    Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. 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 heartbeat.

    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 non-prescription). 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
    • high blood pressure
    • you have asthma

    Ask a doctor or pharmacist before use if you are taking

    • any other drug containing an NSAID (prescription or non-prescription)
    • a blood thinning (anticoagulant) or steroid drug
    • a prescription drug for diabetes, gout, or arthritis
    • any other drug, or are under a doctor’s care for any serious condition

    Stop use and ask doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • ringing in the ears or loss of hearing occurs
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever gets worse or lasts for more than 3 days
    • any new symptoms appear

    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 children even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed (see overdose warning)
    • drink a full glass of water with each dose
    • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
    • children under 12 years of age: ask a doctor
  • Other information

    • store at 68ºF – 77ºF (20ºC – 25ºC)
  • Inactive ingredients

    hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylprrolidone, pregelatinzed starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

  • Questions

    1-866-255-5197

    GoodysPowder.com

  • PRINCIPAL DISPLAY PANEL

    Goody’s EXTRA STRENGTH
    Acetaminophen ● Aspirin (NSAID)/ Caffeine
    Pain Reliever ● Pain Reliever Aid
    100 Caplets

    PRINCIPAL DISPLAY PANEL
Goody’s EXTRA STRENGTH

  • INGREDIENTS AND APPEARANCE
    GOODYS PM PAIN RELIEVER 
    acetaminophen and aspirin and caffeine capsule, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-062
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULESize17mm
    FlavorImprint Code 2793
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63029-062-241 in 1 BOX
    124 in 1 BOTTLE
    2NDC:63029-062-101 in 1 CARTON
    2100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34307/13/2012
    Labeler - Medtech Products Inc. (122715688)

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