Label: GOODYS MIGRAINE RELIEF- acetaminophen, aspirin and caffeine capsule, coated

  • 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 April 18, 2013

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    (in each caplet)

    Acetaminophen 250 mg

    Aspirin 250 mg (NSAID*)

    * nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever

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  • Active ingredient

    (in each caplet)

    Caffeine 65 mg

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  • Purpose

    Pain reliever aid

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  • Use

    • treats migraine
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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
    • asthma (wheezing)
    • shock

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if you take

    • more than 2 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 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: 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 take this product 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 acetaminophen, 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 never had migraines diagnosed by a health professional
    • you have a headache that is different from your usual migraines
    • you have the worse headache of your life
    • you have fever and stiff neck 
    • you have headaches beginning after or caused by head injury, exertion, coughing or bending
    • you experienced your first headache after the age of 50
    • you have daily headaches
    • you have a migraine so severe as to require bed rest
    • 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
    • you have problems or serious side effects from taking pain relievers or fever reducers
    • you have vomiting with your migraine headache

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for:
      ● anticoagulation (thinning of the blood)
      ● diabetes
      ● gout
      ● arthritis
    • under a doctor’s care for any serious condition
    • take any other drug
    • taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer      

    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
    • your migraine is not relieved or worsens after first dose
    • new or unexpected symptoms occur
    • ringing in the ears or a loss of hearing occurs

    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.

    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 
    • adults: take 2 caplets with a glass of water
    • if symptoms persists or worsen, ask a doctor
    • do not take more than 2 caplets in 24 hours, unless directed by a doctor
    • under 18 years of age: ask a doctor
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  • Other information

    • store below 20ºC-25ºC (68º-77ºF)
    • read all product information before using.
      Keep this box for important information.
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  • Inactive ingredients

    carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

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  • Questions or comments?

    1-866-255-5197 GoodysPowders.com

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  • PRINCIPAL DISPLAY PANEL

    Goody’s MIGRAINE RELIEF
    Acetaminophen, Asprin (NSAID) / Caffeine
    Pain Reliever/ Pain Reliever Aid
    100 COATED CAPLETS**
    (** capsule-shaped tablets)

    Goody’s MIGRAINE RELIEF
Acetaminophen, Asprin (NSAID) / Caffeine
Pain Reliever/ Pain Reliever Aid
100 COATED CAPLETS**
(** capsule-shaped tablets)

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  • INGREDIENTS AND APPEARANCE
    GOODYS MIGRAINE RELIEF 
    acetaminophen, aspirin and caffeine capsule, coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-612
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
    CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg
    Inactive Ingredients
    Ingredient Name Strength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CROSPOVIDONE (UNII: 68401960MK)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POVIDONES (UNII: FZ989GH94E)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL Size 17mm
    Flavor Imprint Code L374
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63029-612-01 1 in 1 BOX
    1 100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part343 11/01/2012
    Labeler - Medtech Products Inc. (122715688)
    Establishment
    Name Address ID/FEI Business Operations
    Block Drug Company Inc 001647320 ANALYSIS(63029-612) , LABEL(63029-612) , MANUFACTURE(63029-612) , PACK(63029-612)
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