GOODYS EXTRA STRENGTH- 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 Powders

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS

ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
BOX of 24 ENVELOPES CONTAINING 6 POWDERS EACH

Drug Facts

Active ingredients

(in each powder):
Acetaminophen 260 mg
Aspirin (NSAID*) 520 mg
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aid

Uses

• temporarily relieves minor aches and pains due to:

• headache
• minor arthritis pain
• muscle aches
• colds

• temporarily reduces fever

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).

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Stomach bleeding warning: This product contains a 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, food, 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 sights 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 (1-800-222-1222) 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

lactose monohydrate, potassium chloride

Questions or comments?

1-866-255-5197

PRINCIPAL DISPLAY PANEL

FAST PAIN RELIEF
Goody’s
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
24 envelopes containing 6 powders

Goody’s Extra Strength 24 Envelopes of 6 Powders Carton

PRINCIPAL DISPLAY PANEL

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
18 Powders

Goody’s Extra Strength 18 Powders Carton

PRINCIPAL DISPLAY PANEL

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
24 Powders

Goody’s Extra Strength 24 Powders Carton

PRINCIPAL DISPLAY PANEL

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
50 Powders

Goody’s Extra Strength 50 Powders Carton

PRINCIPAL DISPLAY PANEL

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
2 Powder Stick Packs

Goodys Extra Strength 2 ct Powder Stick Pack

GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-662
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM (UNII: RWP5GA015D)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-662-016 in 1 BOX; Type 0: Not a Combination Product11/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/01/2013
GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-655
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM (UNII: RWP5GA015D)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-655-0118 in 1 BOX; Type 0: Not a Combination Product11/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/01/2013
GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-633
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM (UNII: RWP5GA015D)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-633-0124 in 1 BOX; Type 0: Not a Combination Product11/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/01/2013
GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-644
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM (UNII: RWP5GA015D)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-644-0150 in 1 BOX; Type 0: Not a Combination Product11/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/01/2013
GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-677
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32.5 mg
Inactive Ingredients
Ingredient NameStrength
POTASSIUM (UNII: RWP5GA015D)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-677-012 in 1 PACKET; Type 0: Not a Combination Product11/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/01/2013
Labeler - Medtech Products Inc. (122715688)

Revised: 12/2017
Document Id: ffed5ce7-9441-48be-b5bb-e494e7c5020b
Set id: 16d774cc-4247-4bf8-9b5a-c338ffebda3d
Version: 3
Effective Time: 20171208
 
Medtech Products Inc.