Goodys Extra Strength Powder
FDA Label NDC 63029-644

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Goodys Extra Strength (NDC 63029-644). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings:, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

(in each powder):
Acetaminophen 260 mg
Aspirin (NSAID*) 520 mg
Caffeine 32.5 mg
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer
Pain reliever/fever reducer
Pain reliever aid

Uses

• temporarily relieves minor aches and pains due to:

• headache
• minor arthritis pain
• muscle aches
• colds

• temporarily reduces fever

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.

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.

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.

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.

Other Information

  • each powder contains: potassium 60 mg
  • store below 25°C (77°F)

Inactive Ingredients

lactose monohydrate, potassium chloride

Questions Or Comments?

1-866-255-5197

Principal Display Panel

FAST PAIN RELIEF
Goody’s
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
24 envelopes containing 6 powders

Goody’s Extra Strength 24 Envelopes Of 6 Powders Carton (Goodys Extra Strength Headache Powders 01)

Goody’s Extra Strength 24 Envelopes Of 6 Powders Carton (Goodys Extra Strength Headache Powders 01)

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
18 Powders

Goody’s Extra Strength 18 Powders Carton (Goodys Extra Strength Headache Powders 02)

Goody’s Extra Strength 18 Powders Carton (Goodys Extra Strength Headache Powders 02)

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
2 Powder Stick Packs

Principal Display Panel

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
24 Powders

Goody’s Extra Strength 24 Powders Carton (Goodys Extra Strength Headache Powders 03)

Goody’s Extra Strength 24 Powders Carton (Goodys Extra Strength Headache Powders 03)

FAST PAIN RELIEF
Goody’s®
EXTRA STRENGTH
HEADACHE POWDERS
ACETAMINOPHEN • ASPIRIN (NSAID) / CAFFEINE
PAIN RELIEVER / PAIN RELIEVER AID
50 Powders

Goody’s Extra Strength 50 Powders Carton (Goodys Extra Strength Headache Powders 04)

Goody’s Extra Strength 50 Powders Carton (Goodys Extra Strength Headache Powders 04)

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