GOODYS COOL ORANGE HEADACHE- acetaminophen and aspirin and caffeine powder

Goodys by

Drug Labeling and Warnings

Goodys by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• hives
  
• facial swelling
  
• shock
  
• asthma (wheezing)

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

• more than 4,000 mg of acetaminophen in 24 hours
  
• 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, 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

• 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

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

INGREDIENTS AND APPEARANCE

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)