GOODYS MIGRAINE RELIEF- acetaminophen, aspirin and caffeine capsule, coated 
Medtech Products Inc.

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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Goodys Migraine Relief

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

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

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

Other 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)

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

GOODYS MIGRAINE RELIEF 
acetaminophen, aspirin and caffeine capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63029-612
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeOVALSize17mm
FlavorImprint Code L374
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63029-612-011 in 1 BOX
1100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/01/2012
Labeler - Medtech Products Inc. (122715688)
Establishment
NameAddressID/FEIBusiness Operations
Block Drug Company Inc001647320ANALYSIS(63029-612) , LABEL(63029-612) , MANUFACTURE(63029-612) , PACK(63029-612)

Revised: 4/2013
Document Id: 74962c65-4d94-4b8f-aee8-9d8917745998
Set id: d7bb5c59-2cb8-4b01-a718-c2f342b60612
Version: 2
Effective Time: 20130418
 
Medtech Products Inc.