GOODYS EXTRA STRENGTH- acetaminophen, aspirin, and caffeine powder
Goodys Extra Strength by
Drug Labeling and Warnings
Goodys Extra Strength 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
- Active ingredients (in each powder):
- 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).
Acetaminophen may cause severe skin reactions. Symptoms may include: ▪ skin reddening ▪ blisters ▪ rash. If a skin reaction occurs, stop use and seek medical help right away.
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 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: This product contains caffeine. Limit the use of caffeine-containing medications, foods, or beverages 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 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
- the blood thinning drug warfarin
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 stool
● 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.
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 for children even if you do not notice any signs or symptoms.
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Directions:
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do not take more than directed (see overdose warning)
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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 may 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.
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do not take more than directed (see overdose warning)
- Other information
- Inactive ingredient
- Questions?
- Principal Display Panel
- Principal Display Panel
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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: 63029-625 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 LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POTASSIUM (UNII: RWP5GA015D) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 63029-625-02 2 in 1 PACKAGE; Type 0: Not a Combination Product 11/01/2013 2 NDC: 63029-625-06 6 in 1 CARTON; Type 0: Not a Combination Product 11/01/2013 3 NDC: 63029-625-18 18 in 1 CARTON; Type 0: Not a Combination Product 11/01/2013 4 NDC: 63029-625-24 24 in 1 CARTON; Type 0: Not a Combination Product 11/01/2013 5 NDC: 63029-625-50 50 in 1 CARTON; 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 NOT FINAL part343 11/01/2013 Labeler - Medtech Products Inc. (122715688)
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