goodys cool orange headache powder

goodys cool orange headache powder
SPL v7
SPL
SPL Set ID 31212c97-9975-427e-bc3d-f7125f30299a
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) caffeine (65 mg)
Inactive Ingredients
silicon dioxide guar gum mannitol cellulose, microcrystalline sucralose

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-06-01

Purpose

Acetaminophen 325 mg...........             Pain reliever Aspirin (NSAID*) 500 mg.......             Pain reliever Caffeine 65 mg.........................................       Pain reliever aid *nonsteroidal anti-inflammatory drug

Description

Drug Facts


Medication Information

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 nonprescription 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, andoccasionally, rapid heart beat.

Uses

Temporarily relieves minor aches and pains due to:

•headache             •backache             •toothache

•menstrual cramps       •muscular aches       •a cold

•minor arthritis pain

Purpose

Acetaminophen 325 mg...........             Pain reliever Aspirin (NSAID*) 500 mg.......             Pain reliever Caffeine 65 mg.........................................       Pain reliever aid *nonsteroidal anti-inflammatory drug

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 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
Other Information

Store below 25ºC (77º)F

Inactive Ingredients

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

Description

Drug Facts

Principal Display Panel

Goody’s ®

COOL ORANGE POWDER

ACETAMINOPHEN/ASPIRIN (NSAID)/ CAFFEINE

PAIN RELIEVER / PAIN RELIEVER AID

24 POWDERS

Section 42229-5

Drug Facts

Purposes

Acetaminophen 325 mg...........             Pain reliever

Aspirin (NSAID*) 500 mg.......             Pain reliever

Caffeine 65 mg.........................................       Pain reliever aid

*nonsteroidal anti-inflammatory drug

Questions

1-866-255-5197

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
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 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 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 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.

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

Structured Label Content

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 nonprescription 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, andoccasionally, rapid heart beat.

Uses

Temporarily relieves minor aches and pains due to:

•headache             •backache             •toothache

•menstrual cramps       •muscular aches       •a cold

•minor arthritis pain

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 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
Other Information (Other information)

Store below 25ºC (77º)F

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Goody’s ®

COOL ORANGE POWDER

ACETAMINOPHEN/ASPIRIN (NSAID)/ CAFFEINE

PAIN RELIEVER / PAIN RELIEVER AID

24 POWDERS

Section 42229-5 (42229-5)

Drug Facts

Purposes

Acetaminophen 325 mg...........             Pain reliever

Aspirin (NSAID*) 500 mg.......             Pain reliever

Caffeine 65 mg.........................................       Pain reliever aid

*nonsteroidal anti-inflammatory drug

Questions

1-866-255-5197

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.
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 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, (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 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.

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

Advanced Ingredient Data


Raw Label Data

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