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Goodys

Medtech Products Inc.

Goodys Cool Orange Headache Powder




FULL PRESCRIBING INFORMATION

Drug Facts

(in each powder)

Acetaminophen 325 mg

Aspirin (NSAID*) 500 mg

*nonsteroidal anti-inflammatory drug

Pain reliever/fever reducer

(in each powder)

Caffeine 65 mg

Pain reliever aid

  • temporarily relieves minor aches and pains due to:
    • headache
    • menstrual cramps
    • backache
    • muscular aches
    • toothache
    • colds

  • temporarily reduces fever

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
  • 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.
  • 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

taking a prescription drug for diabetes, gout, or arthritis

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.

  • 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.

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.

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.

  • 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 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
  • store below 25ºC (77º)F

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

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

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

Goody’s COOL ORANGE EXTRA STRENGTH HEADACHE POWDERS
24 SEALED POWER PACKS

Goodys

Goodys

Acetaminophen and Aspirin and Caffeine POWDER

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63029-663
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
aspirin ASPIRIN 500 mg
CAFFEINE 65 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
GUAR GUM
mannitol
cellulose, microcrystalline
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63029-663-01 24 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-06-01


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Be sure to consult your doctor before taking any medication!
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