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 260 mg

Aspirin (NSAID*) 520 mg

Caffeine 32.5 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Pain reliever aid

Uses

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:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

 

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

Do not use

Ask a doctor before use if

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

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

Other information

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

Goody's Headache Powder 50ct


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 DescriptionMultilevel Packaging
1NDC:10158-001-012 POWDER ( PACKET) in 1 PACKAGENone
2NDC:10158-001-026 POWDER ( PACKET) in 1 CARTONNone
3NDC:10158-001-0324 POWDER ( PACKET) in 1 CARTONNone
4NDC:10158-001-0450 POWDER ( PACKET) in 1 CARTONNone
5NDC:10158-001-1918 POWDER ( PACKET) in 1 CARTONNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/08/2010

Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 06/2011 GlaxoSmithKline Consumer Healthcare LP