Goodys Back And Body Pain (Acetaminophen And Asprin) Powder [Medtech Products Inc.] -

GOODYS BACK AND BODY PAIN (ACETAMINOPHEN AND ASPRIN) POWDER [MEDTECH PRODUCTS INC.]
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NDC	63029-600-01, 63029-600-06
Set ID	055d0288-61d4-48bc-b91f-6ecc1969beb8
Category	HUMAN OTC DRUG LABEL
Packager	Medtech Products Inc.
Generic Name
Product Class
Product Number
Application Number	PART343

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredients

(in each caplet)
Acetaminophen 325 mg
Aspirin (NSAID*) 500 mg
*nonsteroidal anti-inflammatory drug
Purpose

Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains due to:
  • headache
  • minor arthritis pain
  • muscular 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 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 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 non-prescription). 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
- the blood thinning drug warfarin
Stop use and ask 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 for more than 10 days
- fever gets worse or lasts for 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 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 49 mg
- store at 25ºC (77ºF)
Inactive ingredients

lactose monohydrate, potassium chloride
Questions or comments?

1-866-255-5197
PRINCIPAL DISPLAY PANEL

Goody’s BACK & BODY PAIN
Acetaminophen
Aspirin (NSAID)
Pain Reliever
Fever Reducer
24 POWDERS

INGREDIENTS AND APPEARANCE

GOODYS BACK AND BODY PAIN
acetaminophen and asprin powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63029-600
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg

Ingredient Name	Strength
Inactive Ingredients
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63029-600-01	24 in 1 BOX; Type 0: Not a Combination Product	06/01/2012
2	NDC:63029-600-06	6 in 1 BOX; Type 0: Not a Combination Product	06/01/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part343	06/01/2012

Labeler - Medtech Products Inc. (122715688)

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Medic

GOODYS BACK AND BODY PAIN (ACETAMINOPHEN AND ASPRIN) POWDER [MEDTECH PRODUCTS INC.]

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are taking

Stop use and ask doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

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