Goodys Back And Body Pain

Goodys Back And Body Pain
SPL v7
SPL
SPL Set ID 055d0288-61d4-48bc-b91f-6ecc1969beb8
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Aspirin (500 mg)
Inactive Ingredients
Lactose Monohydrate Potassium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses
  • temporarily relieves minor aches and pains due to:

    • headache

    • minor arthritis pain

    • muscular aches

    • a cold

  • toothache

  • menstrual cramps

    • temporarily reduces fever
Section 42229-5

Drug Facts

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)

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 packs 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
Questions

1-866-255-5197 



Directions
  • do not take more than directed (see overdose warning)

  • adults and children 12 years of age and over: Open 1 pack, place 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 packs in 24 hours unless directed by a doctor.

  • children under 12 years of age: ask a doctor.
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.
Other Information
  • each powder contains: potassium 49 mg

  • store at 25ºC (77ºF)
Overdose Warning:

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact 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.

Active Ingredients

(in each caplet)

Acetaminophen 325 mg

Aspirin (NSAID*) 500 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

lactose monohydrate, potassium chloride

Principal Display Panel

Goody’s BACK & BODY PAIN

Acetaminophen

Aspirin (NSAID)

Pain Reliever

Fever Reducer

24 POWDERS

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
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

  • pain gets worse or lasts for more than 10 days

  • fever gets worse or lasts for 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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Ask A Doctor Or Pharmacist Before Use If You Are Taking
  • a prescription drug for diabetes, gout, or arthritis

  • the blood thinning drug warfarin

Structured Label Content

Uses
  • temporarily relieves minor aches and pains due to:

    • headache

    • minor arthritis pain

    • muscular aches

    • a cold

  • toothache

  • menstrual cramps

    • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain reliever/fever reducer

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)

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 packs 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
Questions

1-866-255-5197 



Directions
  • do not take more than directed (see overdose warning)

  • adults and children 12 years of age and over: Open 1 pack, place 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 packs in 24 hours unless directed by a doctor.

  • children under 12 years of age: ask a doctor.
Do Not Use (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.
Other Information (Other information)
  • each powder contains: potassium 49 mg

  • store at 25ºC (77ºF)
Overdose Warning: (Overdose warning:)

Taking more than the recommended dose can cause serious health problems. In case of overdose, get medical help or contact 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.

Active Ingredients (Active ingredients)

(in each caplet)

Acetaminophen 325 mg

Aspirin (NSAID*) 500 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, potassium chloride

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Goody’s BACK & BODY PAIN

Acetaminophen

Aspirin (NSAID)

Pain Reliever

Fever Reducer

24 POWDERS

Ask A Doctor Before Use If (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
Stop Use and Ask Doctor If (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

  • pain gets worse or lasts for more than 10 days

  • fever gets worse or lasts for 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, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Ask A Doctor Or Pharmacist Before Use If You Are Taking (Ask a doctor or pharmacist before use if you are taking)
  • a prescription drug for diabetes, gout, or arthritis

  • the blood thinning drug warfarin

Advanced Ingredient Data


Raw Label Data

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