GOODYS PM PAIN RELIEVER- acetaminophen and aspirin and caffeine capsule, coated

Goodys PM Pain Reliever by

Drug Labeling and Warnings

Goodys PM Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID**) 250 mg

**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Active ingredient

(in each caplet)

Caffeine 65 mg

Purpose

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to

• headache
  
• minor arthritis pain
  
• muscle aches
  
• colds

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 8 caplets 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

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine – containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

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
  
• high blood pressure
  
• you have asthma

Ask a doctor or pharmacist before use if you are taking

• any other drug containing an NSAID (prescription or non-prescription)
  
• a blood thinning (anticoagulant) or steroid drug
  
• a prescription drug for diabetes, gout, or arthritis
  
• any other drug, or are under a doctor’s care for any serious condition

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
  
• ringing in the ears or loss of hearing occurs
  
• painful area is red or swollen
  
• pain gets worse or lasts for more than 10 days
  
• fever gets worse or lasts for more than 3 days
  
• any new symptoms appear

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 (1-800-222-1222) 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)
  
• drink a full glass of water with each dose
  
• adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
  
• children under 12 years of age: ask a doctor

Other information

• store at 68ºF – 77ºF (20ºC – 25ºC)

Inactive ingredients

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylprrolidone, pregelatinzed starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

Questions

1-866-255-5197

GoodysPowder.com

PRINCIPAL DISPLAY PANEL

Goody’s EXTRA STRENGTH
Acetaminophen ● Aspirin (NSAID)/ Caffeine
Pain Reliever ● Pain Reliever Aid
100 Caplets

INGREDIENTS AND APPEARANCE

GOODYS PM PAIN RELIEVER 
acetaminophen and aspirin and caffeine capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-062
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYDEXTROSE (UNII: VH2XOU12IE)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	2793
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-062-24	1 in 1 BOX
1		24 in 1 BOTTLE
2	NDC: 63029-062-10	1 in 1 CARTON
2		100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part343	07/13/2012

Labeler - Medtech Products Inc. (122715688)