GOODYS EXTRA STRENGTH- acetaminophen, aspirin, and caffeine powder

Goodys Extra Strength by

Drug Labeling and Warnings

Goodys Extra Strength 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

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

• 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.

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:

• 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 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

• each powder contains: potassium 60 mg
  
• store below 25°C (77°F)

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

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

INGREDIENTS AND APPEARANCE

GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-662
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.5 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM (UNII: RWP5GA015D)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-662-01	6 in 1 BOX; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/01/2013

GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-655
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.5 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM (UNII: RWP5GA015D)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-655-01	18 in 1 BOX; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/01/2013

GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-633
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.5 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM (UNII: RWP5GA015D)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-633-01	24 in 1 BOX; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/01/2013

GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-644
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.5 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM (UNII: RWP5GA015D)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-644-01	50 in 1 BOX; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/01/2013

GOODYS EXTRA STRENGTH 
acetaminophen, aspirin, and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-677
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	260 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	520 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	32.5 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM (UNII: RWP5GA015D)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-677-01	2 in 1 PACKET; Type 0: Not a Combination Product	11/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	11/01/2013

Labeler - Medtech Products Inc. (122715688)