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

Purpose

Pain reliever Pain reliever Pain reliever aid

Description

Drug Facts


Medication Information

Uses

Temporarily relieves minor aches and pains due to:

      • headache                   • minor arthritis pain

      • muscular aches             • a cold

      • backache                   • toothache

      • menstrual cramps

Purpose

Pain reliever Pain reliever Pain reliever aid

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.

Other Information

▪ store below 25°C (77°F)

Inactive Ingredients

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

Description

Drug Facts

Principal Display Panel

Goody’s Mixed Fruit Blast

Acetaminophen/ Aspirin (NSAID)/ Caffeine

Pain reliever/ Pain Reliever Aid

24 POWDERS



Questions?

1-866-255-5197 goodyspowder.com

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.

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.

Active Ingredients

(in each powder ):                                             

Acetaminophen 325 mg 

Aspirin (NSAID*) 500 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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

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.

Other Information (Other information)

▪ store below 25°C (77°F)

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



Questions?

1-866-255-5197 goodyspowder.com

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.

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.

Active Ingredients (Active ingredients)

(in each powder ):                                             

Acetaminophen 325 mg 

Aspirin (NSAID*) 500 mg

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

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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Raw Label Data

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