FDA.reportPublic FDA data

Goodys Extra Strength

Manufacturer
Medtech Products Inc.
Effective date
2024-10-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:31:50

Label at a glance#

ProductGoodys Extra Strength
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure14 sections

Indications and uses

• temporarily relieves minor aches and pains due to: • headache • minor arthritis pain • muscle aches • colds • temporarily reduces fever

Dosage and administration

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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

OTC - ACTIVE INGREDIENT SECTION

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

Purposes

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

• temporarily relieves minor aches and pains due to:

• headache
• minor arthritis pain 		• muscle aches
• colds

• temporarily reduces fever

Warnings:

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug for diabetes, gout, or arthritis

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning:

OVERDOSAGE SECTION

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:

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

lactose monohydrate, potassium chloride

Questions or comments?

OTC - QUESTIONS SECTION

1-866-255-5197 (English/Spanish) weekdays

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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

FAST PAIN RELIEF Goody’s® EXTRA STRENGTH HEADACHE POWDERS ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE PAIN RELIEVER / PAIN RELIEVER AID 24 ENVELOPES CONTAINING 6 POWDERS EACHFAST 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
763116acetaminophen 260 MG / aspirin 520 MG / caffeine 32.5 MG Oral PowderPSN5
763116acetaminophen 260 MG / aspirin 520 MG / caffeine 32.5 MG Oral PowderSCD5
763116APAP 260 MG / ASA 520 MG / Caffeine 32.5 MG Oral PowderSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-633-012020-07-01C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-644-012020-07-01C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-655-012020-07-01C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-662-012020-07-01C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-677-012020-07-01C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-633-012020-01-31C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-644-012020-01-31C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-655-012020-01-31C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-662-012020-01-31C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders
63029-677-012020-01-31C16284748780-19d75b9d0-c5e6-f424-e053-dadaa90a57ceGoodys Extra Strength Headache Powders

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-633-01Goodys Extra Strength24 in 1 BOXPOWDER245
63029-644-01Goodys Extra Strength50 in 1 BOXPOWDER505
63029-655-01Goodys Extra Strength18 in 1 BOXPOWDER185
63029-662-01Goodys Extra Strength6 in 1 BOXPOWDER65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-633GOODYS EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]5Legacy NDC, 1 package rows20241101_16d774cc-4247-4bf8-9b5a-c338ffebda3d.zip
63029-644GOODYS EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]5Current NDC, Legacy NDC, 1 package rows20241101_16d774cc-4247-4bf8-9b5a-c338ffebda3d.zip
63029-655GOODYS EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]5Legacy NDC, 1 package rows20241101_16d774cc-4247-4bf8-9b5a-c338ffebda3d.zip
63029-662GOODYS EXTRA STRENGTH (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) POWDER [MEDTECH PRODUCTS INC.]5Legacy NDC, 1 package rows20241101_16d774cc-4247-4bf8-9b5a-c338ffebda3d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-662-01EA - Each63029-6621a3ff3c5-6244-4643-93f5-cc3c7a772c2412022-06-06
63029-633-01EA - Each63029-633ac8d4385-921e-48ee-af59-2ae416a335a112022-06-06
63029-644-01EA - Each63029-6448dd4b674-8cb1-4a69-a7f6-43e8af8484f912022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ASPIRINACTIVE INGREDIENTR16CO5Y76E2
CAFFEINEACTIVE INGREDIENT3G6A5W338E2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
ASPIRINACTIVE MOIETYR16CO5Y76E2
CAFFEINEACTIVE MOIETY3G6A5W338E2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X2
POTASSIUMINACTIVE INGREDIENTRWP5GA015D2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63029-66263029-662-01
63029-65563029-655-01
63029-63363029-633-01
63029-64463029-644-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB
POTASSIUMRWP5GA015DIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB
POTASSIUMRWP5GA015DIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB
POTASSIUMRWP5GA015DIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
ACETAMINOPHEN362O9ITL9DACTIB
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB
POTASSIUMRWP5GA015DIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XPOWDER / ORAL50 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XPOWDER / ORAL50 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.16d774cc-4247-4bf8-9b5a-c338ffebda3d2024-10-25WarningsExact identifier
ndc (package): 63029-644-01
ndc (package): 63029-655-01
ndc (package): 63029-662-01
ndc (package): 63029-633-01
ndc (product): 63029-655
ndc (product): 63029-633
ndc (product): 63029-644
ndc (product): 63029-662
ndc11 (package): 63029065501
ndc11 (package): 63029063301
ndc11 (package): 63029064401
ndc11 (package): 63029066201
spl id: fcd02d17-893b-44ea-870f-29d2ae58a9b9
spl set id: 16d774cc-4247-4bf8-9b5a-c338ffebda3d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.