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)

Purposes

Acetaminophen 325 mg...........             Pain reliever

Aspirin (NSAID*) 500 mg.......             Pain reliever

Caffeine 65 mg.........................................       Pain reliever aid

*nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains due to:

      •headache             •backache             •toothache

      •menstrual cramps       •muscular aches       •colds

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:

Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash. If a skin reaction occurs, stop use and seek medical help right away.

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

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, andoccasionally, 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 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

Store below 25ºC (77º)F

Inactive ingredients

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

Questions ? 1-866-255-5197 

PRINCIPAL DISPLAY PANEL

Goody’s ®

COOL ORANGE POWDER

ACETAMINOPHEN/ASPIRIN (NSAID)/ CAFFEINE

PAIN RELIEVER / PAIN RELIEVER AID

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-663
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GUAR GUM (UNII: E89I1637KE)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-663-0124 in 1 BOX; Type 0: Not a Combination Product06/01/2012
2NDC:63029-663-044 in 1 BOX; Type 0: Not a Combination Product06/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/01/2012
Labeler - Medtech Products Inc. (122715688)

Revised: 4/2020
Document Id: 9aaee80c-3923-453e-b0d3-c0b8825f6675
Set id: 31212c97-9975-427e-bc3d-f7125f30299a
Version: 5
Effective Time: 20200409
 
Medtech Products Inc.