Label: GOODYS COOL ORANGE- acetaminophen, aspirin, and caffeine powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 September 16, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients (in each powder) Purposes
    *
    nonsteroidal anti-inflammatory drug
    Acetaminophen 325 mg Pain reliever
    Aspirin (NSAID*) 500 mg Pain reliever
    Caffeine 65 mg Pain reliever aid
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  • Uses

    • temporarily relieves minor aches and pains due to:
      • headache
      • backache
      • toothache
      • menstrual cramps
      • muscular aches
      • colds
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  • 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 a longer time than directed

    Caffeine warning

    This product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

    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
    • The blood thinning drug warfarin

    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
      • 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.

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  • 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.
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  • Other information

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

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

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  • Questions or comments?

    1-866-255-5197 goodyspowder.com

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  • SPL UNCLASSIFIED SECTION

    Manufactured by Medtech Products Inc., Tarrytown, NY 10591

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  • PRINCIPAL DISPLAY PANEL - 2 Packet Carton

    ORANGE
    FLAVOR

    FAST PAIN RELIEF

    Goody's®

    COOL ORANGE
    EXTRA
    STRENGTH

    ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
    PAIN RELIEVER / PAIN RELIEVER AID

    Goody's®
    COOL ORANGE
    HEADACHE POWDERS

    2 SEALED
    POWDER PACKS

    Lil'
    Drug Store®

    PRINCIPAL DISPLAY PANEL - 2 Packet Carton
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  • INGREDIENTS AND APPEARANCE
    GOODYS COOL ORANGE 
    acetaminophen, aspirin, and caffeine powder
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-5301(NDC:63029-663)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 500 mg
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Guar Gum (UNII: E89I1637KE)  
    Mannitol (UNII: 3OWL53L36A)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    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:66715-5301-3 2 in 1 CARTON
    1 1 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 03/01/2014
    Labeler - Lil' Drug Store Products, Inc (093103646)
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