GOODYS COOL ORANGE HEADACHE- acetaminophen and aspirin and caffeine powder 
Medtech Products Inc.

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.

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Goodys Cool Orange Headache Powder

Drug Facts

Active ingredients (in each powder)

Acetaminophen 325 mg

Active ingredients (in each powder)

Aspirin (NSAID*) 500 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Active ingredient (in each powder)

Caffeine 65 mg

Purpose

Pain reliever aid

Uses

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:

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

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
    • 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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

Inactive ingredients

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

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL
Goody’s COOL ORANGE EXTRA STRENGTH HEADACHE POWDERS
24 SEALED POWDER PACKS

GOODYS  COOL ORANGE HEADACHE
acetaminophen and aspirin and caffeine powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) 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)  
GUAR GUM (UNII: E89I1637KE)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color      Score     
Shape Size
Flavor ORANGE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63029-663-01 24 in 1 BOX; Type 0: Not a Combination Product 06/01/2012
2 NDC:63029-663-04 4 in 1 BOX; Type 0: Not a Combination Product 06/01/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 06/01/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 2/2017
Document Id: 6b4c0db1-fb76-4637-93a4-be880dbcb280
Set id: 31212c97-9975-427e-bc3d-f7125f30299a
Version: 4
Effective Time: 20170228
 
Medtech Products Inc.