FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS

ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
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 (English/Spanish) weekdays

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 EACH

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63029-662-01	6 in 1 BOX; Type 0: Not a Combination Product	11/01/2013	11/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	11/01/2013	11/30/2023

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63029-655-01	18 in 1 BOX; Type 0: Not a Combination Product	11/01/2013	11/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	11/01/2013	11/30/2023

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63029-633-01	24 in 1 BOX; Type 0: Not a Combination Product	11/01/2013	11/30/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	11/01/2013	11/30/2023

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

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

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

Labeler - Medtech Products Inc. (122715688)

Goodys Extra Strength Headache Powders

Active ingredients

Purposes

Uses

Warnings:

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Overdose warning:

Directions:

Other information

Inactive ingredients

Questions or comments?

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