GOODYS - acetaminophen, aspirin and caffeine powder
GlaxoSmithKline Consumer Healthcare LP

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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Active ingredients (in each powder)

Acetaminophen 325 mg

Aspirin (NSAID*) 500 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:
- headache
- menstrual cramps
- backache
- muscular aches
- toothache
- 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 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
- have bloody or black stools
- have stomach pain that does not get better
- vomit blood
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

store below 25°C (77°F)

Inactive ingredients

colloidal silicon dioxide, flavors, guar gum, mannitol, microcrystalline cellulose, sucralose

Questions or comments?

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

TAMPER EVIDENT FEATURE: DO NOT USE IF PACKET IS DAMAGED OR OPEN.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

GOODY'S is a registered trademark of the GlaxoSmithKline group of companies.

TO OPEN CHILD-RESISTANT PACKAGE

1.Shake pack so powder settles on bottom.

2. Pinch and tear at either arrow or use scissors.

3. Tilt head back and pour powder onto tongue.

www.goodyspowder.com

Principal Display Panel

NDC 0135-0462-02

Goody's®

COOL ORANGE EXTRA STRENGTH

ACETAMINOPHEN•ASPIRIN (NSAID)/CAFFEINE

PAIN RELIEVER•FEVER REDUCER/ PAIN RELIEVER AID

ORANGE FLAVOR

FAST PAIN RELIEF

HEADACHE POWDERS

24 SEALED POWDER PACKS

29862XF

Goody's Cool Orange 24 count carton

GOODYS
acetaminophen, aspirin, and caffeine powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0135-0462
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	325 mg
ASPIRIN (ASPIRIN)	ASPIRIN	500 mg
CAFFEINE (CAFFEINE)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
GUAR GUM
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SUCRALOSE

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0135-0462-01	4 POWDER ( PACKET) in 1 CARTON	None
2	NDC:0135-0462-02	24 POWDER ( PACKET) in 1 CARTON	None
3	NDC:0135-0462-03	1 POWDER ( PACKET) in 1 PACKAGE	None
4	NDC:0135-0462-05	36 POWDER ( PACKET) in 1 CARTON	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/23/2011

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 09/2011 GlaxoSmithKline Consumer Healthcare LP