GOODYS EXTRA STRENGTH HEADACHE MIXED FRUIT BLAST- acetaminophen, 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 Extra Strength Headache Powder - Mixed Fruit Blast

Drug Facts

Active ingredients

(in each powder):                                             
Acetaminophen 325 mg 
Aspirin (NSAID*) 500 mg
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever
Pain reliever
Pain reliever aid

Uses

Temporarily relieves minor aches and pains due to:

      • headache                   • minor arthritis pain

      • muscular aches             • colds

      • backache                   • toothache

      • menstrual cramps

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 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 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 a 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 non-prescription 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, and, occasionally, 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 stool
▪ 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 Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as 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 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 a 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 25°C (77°F)

Inactive ingredients

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

Questions? 
1-866-255-5197 goodyspowder.com

PRINCIPAL DISPLAY PANEL

Goody’s Mixed Fruit Blast
Acetaminophen/ Aspirin (NSAID)/ Caffeine
Pain reliever/ Pain Reliever Aid

PRINCIPAL DISPLAY PANEL
Goody’s Mixed Fruit Blast
Acetaminophen
Aspirin (NSAID)/ Caffeine
24 sealed powder packs

GOODYS  EXTRA STRENGTH HEADACHE MIXED FRUIT BLAST
acetaminophen, aspirin, and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-664
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN500 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
FlavorFRUIT (Mixed Fruit) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-664-044 in 1 CARTON; Type 0: Not a Combination Product08/01/2015
2NDC:63029-664-2424 in 1 CARTON; Type 0: Not a Combination Product08/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34308/01/2015
Labeler - Medtech Products Inc. (122715688)

Revised: 4/2020
Document Id: 061df2d8-dea3-4024-8546-6bbdbf37c81a
Set id: 6cb758bf-5a50-46bb-96e7-65b810b12de0
Version: 3
Effective Time: 20200409
 
Medtech Products Inc.