Label: GOODYS- acetaminophen, aspirin and caffeine powder

  • NDC Code(s): 0135-0462-01, 0135-0462-02, 0135-0462-03, 0135-0462-05
  • Packager: GlaxoSmithKline Consumer Healthcare LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 09/13

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

  • Active ingredients (in each powder)

    Acetaminophen 325 mg

    Aspirin (NSAID*) 500 mg

    Caffeine 65 mg

    *nonsteroidal anti-inflammatory drug

    Close
  • Purposes

    Pain reliever/fever reducer

    Pain reliever/fever reducer

    Pain reliever aid

    Close
  • Uses

    temporarily relieves minor aches and pains due to:
    headache
    menstrual cramps
    backache
    muscular aches
    toothache
    colds
    temporarily reduces fever
    Close
  • 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 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 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 nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    have 3 or more alcoholic drinks every day while using this product
    take more or for 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, foods, 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 signs of stomach bleeding:
    feel faint
    have bloody or black stools
    have stomach pain that does not get better
    vomit blood
    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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    Close
  • Directions

    do not take more than directed (see overdose warning)
    adults and children 12 years of age and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or may 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.
    Close
  • Other information

    store below 25°C (77°F)
    Close
  • Inactive ingredients

    colloidal silicon dioxide, flavors, guar gum, mannitol, microcrystalline cellulose, sucralose

    Close
  • Questions or comments?

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

    TAMPER EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN.

    Distributed by:

    GlaxoSmithKline

    Consumer Healthcare, L.P.

    Moon Township, PA 15108

    ©2011 GlaxoSmithKline

    GOODY'S is a registered trademark of the GlaxoSmithKline group of companies.

    TO OPEN CHILD-RESISTANT PACKAGE

    1.Shake pack so powder settles on bottom.

    2. Pinch and tear at either arrow or use scissors.

    3. Tilt head back and pour powder onto tongue.

    www.goodyspowder.com

    Close
  • Principal Display Panel

    NDC 0135-0462-02

    Goody's®

    COOL ORANGE EXTRA STRENGTH

    ACETAMINOPHEN•ASPIRIN (NSAID)/CAFFEINE

    PAIN RELIEVER•FEVER REDUCER/ PAIN RELIEVER AID

    ORANGE FLAVOR

    FAST PAIN RELIEF

    HEADACHE POWDERS

    24 SEALED POWDER PACKS

    29862XF

    Goody's Cool Orange 24 count carton
    Close
  • INGREDIENTS AND APPEARANCE
    GOODYS 
    acetaminophen, aspirin, and caffeine powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0135-0462
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
    ASPIRIN (ASPIRIN) ASPIRIN 500 mg
    CAFFEINE (CAFFEINE) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    GUAR GUM  
    MANNITOL  
    CELLULOSE, MICROCRYSTALLINE  
    SUCRALOSE  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor ORANGE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0462-01 4 in 1 CARTON
    2 NDC:0135-0462-02 24 in 1 CARTON
    3 NDC:0135-0462-03 1 in 1 PACKAGE
    4 NDC:0135-0462-05 36 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 09/23/2011 12/31/2014
    Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)
    Close