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Goodys

Dosage form: powder
Ingredients: ACETAMINOPHEN 260mg, ASPIRIN 520mg, CAFFEINE 32.5mg
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 10158-001

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.

Drug Facts

Active ingredients (in each powder)

Acetaminophen 260 mg

Aspirin (NSAID*) 520 mg

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Pain reliever/fever reducer

Pain reliever aid

Uses
temporarily relieves minor aches and pains due to:
headache
muscular aches
minor arthritis pain
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 a 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 an 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 nonprescription 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, foods, 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 signs 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 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 of age 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
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

TAMPER EVIDENT FEATURE: DO NOT USE IF SAFETY OVERWRAP OR "S" TEAR-TAPE IS MISSING OR TORN.

Distributed by: GlaxoSmithKline Consumer Healthcare, L.P.

Moon Township, PA 15108

©2011 GlaxoSmithKline

Goody's is a registered trademark of the GlaxoSmithKline group of companies.

Principal Display Panel

NDC 10158-001-04

Goody's®

FAST PAIN RELIEF

EXTRA STRENGTH

HEADACHE POWDERS

ACETAMINOPHEN · ASPIRIN (NSAID)/ CAFFEINE

PAIN RELIEVER· FEVER REDUCER / PAIN RELIEVER AID

50 POWDERS

30641XC

GOODYS 
acetaminophen, aspirin, and caffeine powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10158-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN260 mg
ASPIRIN (ASPIRIN) ASPIRIN520 mg
CAFFEINE (CAFFEINE) CAFFEINE32.5 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE 
POTASSIUM CHLORIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:10158-001-012 POWDER in 1 PACKAGE
2NDC:10158-001-026 POWDER in 1 CARTON
3NDC:10158-001-0450 POWDER in 1 CARTON
4NDC:10158-001-1918 POWDER in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/08/201012/31/2015
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2013
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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