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

Description

Drug Facts

Purpose

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


Medication Information

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

Uses

Temporarily relieves minor aches and pains due to:

•headache             •backache             •toothache

•menstrual cramps       •muscular aches       •a cold

•minor arthritis pain

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

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.

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

Store below 25ºC (77º)F

Inactive Ingredients

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

Principal Display Panel

Goody’s ®

COOL ORANGE POWDER

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 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

Uses

Temporarily relieves minor aches and pains due to:

•headache             •backache             •toothache

•menstrual cramps       •muscular aches       •a cold

•minor arthritis pain

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

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.

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

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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