Label: GOODYS EXTRA STRENGTH- acetaminophen, aspirin, and caffeine powder
- NDC Code(s): 63029-633-01, 63029-644-01, 63029-655-01, 63029-662-01
- Packager: Medtech Products Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2024
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Uses
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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 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 a 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 nonprescription). 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
When using this product
limit the use of caffeine-containing drugs, food, or drinks because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. The recommended dose of this product contains about as much caffeine as a cup of coffee.
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following sights 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 more than 10 days
- fever gets worse or lasts 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.
- more than 4 powders in 24 hours, which is the maximum daily amount
- Overdose warning:
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Directions:
- do not take more than directed (see overdose warning)
- adults and children 12 years and over: place 1 powder on tongue every 6 hours, while symptoms persist. Drink a full glass of water with each dose, or 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.
- do not take more than directed (see overdose warning)
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
GOODYS EXTRA STRENGTH
acetaminophen, aspirin, and caffeine powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-662 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 260 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 520 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.5 mg Inactive Ingredients Ingredient Name Strength POTASSIUM (UNII: RWP5GA015D) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-662-01 6 in 1 BOX; Type 0: Not a Combination Product 11/01/2013 11/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 11/01/2013 11/30/2023 GOODYS EXTRA STRENGTH
acetaminophen, aspirin, and caffeine powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-655 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 260 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 520 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.5 mg Inactive Ingredients Ingredient Name Strength POTASSIUM (UNII: RWP5GA015D) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-655-01 18 in 1 BOX; Type 0: Not a Combination Product 11/01/2013 11/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 11/01/2013 11/30/2023 GOODYS EXTRA STRENGTH
acetaminophen, aspirin, and caffeine powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-633 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 260 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 520 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.5 mg Inactive Ingredients Ingredient Name Strength POTASSIUM (UNII: RWP5GA015D) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-633-01 24 in 1 BOX; Type 0: Not a Combination Product 11/01/2013 11/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 11/01/2013 11/30/2023 GOODYS EXTRA STRENGTH
acetaminophen, aspirin, and caffeine powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-644 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 260 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 520 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 32.5 mg Inactive Ingredients Ingredient Name Strength POTASSIUM (UNII: RWP5GA015D) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63029-644-01 50 in 1 BOX; Type 0: Not a Combination Product 11/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 11/01/2013 Labeler - Medtech Products Inc. (122715688)