Goodys Extra Strength Headache Powder

Goodys Extra Strength Headache Powder
SPL v5
SPL
SPL Set ID 6cb758bf-5a50-46bb-96e7-65b810b12de0
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (65 mg) Acetaminophen (325 mg) Aspirin (500 mg)
Inactive Ingredients
Silicon Dioxide Guar Gum Mannitol Cellulose, Microcrystalline Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-01

Description

Drug Facts

Purpose

Pain reliever Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever Pain reliever Pain reliever aid

Description

Drug Facts

Uses

Temporarily relieves minor aches and pains due to:

      • headache                   • minor arthritis pain

      • muscular aches             • a cold

      • backache                   • toothache

      • menstrual cramps

Section 42229-5

Drug Facts

Purposes

Pain reliever

Pain reliever

Pain reliever aid

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 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 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.

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.

Directions

do not take more than directed (see overdose warning)

a dults and children 12 years 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.

c hildren 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Questions?

1-866-255-5197 goodyspowder.com

Other Information

▪ store below 25°C (77°F)

Active Ingredients

(in each powder ):                                             

Acetaminophen 325 mg 

Aspirin (NSAID*) 500 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients

colloidal silicon dioxide, flavors, guar gum, mannitol, microcrystalline cellulose, sucralose

Principal Display Panel

Goody’s Mixed Fruit Blast

Acetaminophen/ Aspirin (NSAID)/ Caffeine

Pain reliever/ Pain Reliever Aid

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 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 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.

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 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.

Ask A Doctor Or Pharmacist Before Use If You Are Taking

▪ a prescription drug for diabetes, gout, or arthritis


Structured Label Content

Uses

Temporarily relieves minor aches and pains due to:

      • headache                   • minor arthritis pain

      • muscular aches             • a cold

      • backache                   • toothache

      • menstrual cramps

Section 42229-5 (42229-5)

Drug Facts

Purposes

Pain reliever

Pain reliever

Pain reliever aid

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 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 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.

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.

Directions

do not take more than directed (see overdose warning)

a dults and children 12 years 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.

c hildren 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Questions?

1-866-255-5197 goodyspowder.com

Other Information (Other information)

▪ store below 25°C (77°F)

Active Ingredients (Active ingredients)

(in each powder ):                                             

Acetaminophen 325 mg 

Aspirin (NSAID*) 500 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, flavors, guar gum, mannitol, microcrystalline cellulose, sucralose

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Goody’s Mixed Fruit Blast

Acetaminophen/ Aspirin (NSAID)/ Caffeine

Pain reliever/ Pain Reliever Aid

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 A Doctor If (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, (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.

Keep Out of Reach of Children. (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 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.

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


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