GOODYS MIGRAINE RELIEF- acetaminophen, aspirin and caffeine capsule, coated

Goodys Migraine Relief by

Drug Labeling and Warnings

Goodys Migraine Relief by is a Otc medication manufactured, distributed, or labeled by Medtech Products Inc., Block Drug Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

(in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID*)

* nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Active ingredient

(in each caplet)

Caffeine 65 mg

Purpose

Pain reliever aid

Use

• treats migraine

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
  
• asthma (wheezing)
  
• shock

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if you take

• more than 2 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 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

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 take this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use

• if you have ever had an allergic reaction to acetaminophen, 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 never had migraines diagnosed by a health professional
  
• you have a headache that is different from your usual migraines
  
• you have the worse headache of your life
  
• you have fever and stiff neck 
  
• you have headaches beginning after or caused by head injury, exertion, coughing or bending
  
• you experienced your first headache after the age of 50
  
• you have daily headaches
  
• you have a migraine so severe as to require bed rest
  
• 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
  
• you have problems or serious side effects from taking pain relievers or fever reducers
  
• you have vomiting with your migraine headache

Ask a doctor or pharmacist before use if you are

• taking a prescription drug for:
  ● anticoagulation (thinning of the blood)
  ● diabetes
  ● gout
  ● arthritis
  
• under a doctor’s care for any serious condition
  
• take any other drug
  
• taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer      

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
  
• your migraine is not relieved or worsens after first dose
  
• new or unexpected symptoms occur
  
• ringing in the ears or a loss of hearing occurs

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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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 
  
• adults: take 2 caplets with a glass of water
  
• if symptoms persists or worsen, ask a doctor
  
• do not take more than 2 caplets in 24 hours, unless directed by a doctor
  
• under 18 years of age: ask a doctor

Other information

• store below 20ºC-25ºC (68º-77ºF)
  
• read all product information before using.
  Keep this box for important information.

Inactive ingredients

carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

Questions or comments?

1-866-255-5197 GoodysPowders.com

PRINCIPAL DISPLAY PANEL

Goody’s MIGRAINE RELIEF
Acetaminophen, Asprin (NSAID) / Caffeine
Pain Reliever/ Pain Reliever Aid
100 COATED CAPLETS**
(** capsule-shaped tablets)

INGREDIENTS AND APPEARANCE

GOODYS MIGRAINE RELIEF 
acetaminophen, aspirin and caffeine capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63029-612
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (UNII: 68401960MK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONES (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	L374
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63029-612-01	1 in 1 BOX
1		100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	11/01/2012

Labeler - Medtech Products Inc. (122715688)

Establishment
Name	Address	ID/FEI	Business Operations
Block Drug Company Inc		001647320	ANALYSIS(63029-612) , LABEL(63029-612) , MANUFACTURE(63029-612) , PACK(63029-612)