Label: GOODYS MIGRAINE RELIEF- acetaminophen, aspirin and caffeine capsule, coated
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Contains inactivated NDC Code(s)
NDC Code(s): 63029-612-01 - Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated April 18, 2013
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- Active ingredients
- Purpose
- Active ingredient
- Purpose
- Use
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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
- hives
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GOODYS MIGRAINE RELIEF
acetaminophen, aspirin and caffeine capsule, coatedProduct 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)
