Goodys Pm Pain Reliever
FDA Label NDC 63029-062

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 Pm Pain Reliever (NDC 63029-062). 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, purpose, active ingredient, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are taking, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

(in each caplet)

Acetaminophen 250 mg

Aspirin (NSAID**) 250 mg

**nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Pain reliever aid

Active Ingredient

(in each caplet)

Caffeine 65 mg

Uses

temporarily relieves minor aches and pains due to

  • headache
  • minor arthritis pain
  • muscle aches
  • colds

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
  • shock
  • asthma (wheezing)
  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    • more than 8 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 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: 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 taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

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 non-prescription). 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
  • high blood pressure
  • you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are Taking

  • any other drug containing an NSAID (prescription or non-prescription)
  • a blood thinning (anticoagulant) or steroid drug
  • a prescription drug for diabetes, gout, or arthritis
  • any other drug, or are under a doctor’s care for any serious condition

Stop Use And Ask 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
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • any new symptoms appear

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 children even if you do not notice any signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours
  • children under 12 years of age: ask a doctor

Other Information

  • store at 68°F – 77°F (20°C – 25°C)

Inactive Ingredients

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylprrolidone, pregelatinzed starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

Questions

1-866-255-5197

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Goody’s EXTRA STRENGTH
Acetaminophen ● Aspirin (NSAID)/ Caffeine
Pain Reliever ● Pain Reliever Aid
100 Caplets

Principal Display Panelgoody’s Extra Strength (Goodys Extra Strength 01)

Principal Display Panelgoody’s Extra Strength (Goodys Extra Strength 01)

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