Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 0d3798bc-04ef-584e-821b-7aa76036b7d1
Route
ORAL
Published
Effective Date 2020-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (500 mg) Caffeine (60 mg)
Inactive Ingredients
Acesulfame Potassium Anhydrous Citric Acid Aspartame Docusate Sodium Mannitol Povidone Sodium Benzoate Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 25 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-07-23

Description

Aspirin 500 mg (NSAID*) Caffeine 60 mg *Nonsteroidal anti-inflammatory drug

Purpose

Aspirin…..Pain reliever Caffeine…Alertness aid/Pain reliever aid


Medication Information

Purpose

Aspirin…..Pain reliever



Caffeine…Alertness aid/Pain reliever aid

Description

Aspirin 500 mg (NSAID*) Caffeine 60 mg *Nonsteroidal anti-inflammatory drug

Uses
  • for the temporary relief of minor aches and pains associated with a hangover
  • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
  • also for the temporary relief of headaches or body aches and pains alone

  • for the temporary relief of headache pain
  • also temporarily relieves minor aches and pains due to: backache muscle aches arthritis menstrual cramps hangover

  • for the temporary relief of muscle aches and pain
  • helps restore mental alertness when experiencing fatigue
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 Reyes syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning:

This product contains a nonsteroidal anti-inflammatory drug (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
Directions
  • upon waking, fully dissolve 2 tablets in 16 oz. of water and drink
  • do not exceed recommended dosage
Adults and children 12 years and over

(up to 60 years of age)
2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 8 tablets in 24 hours
Adults 60 years and over 2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 4 tablets in 24 hours
Children under 12 years Do not use
Do Not Use
  • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever inducer
Blowfish Sport

Blowfish Sport

Caffeinated Pain Relief

20 effervescent tablets

Lemon Flavor

Alertness Aid - Caffeine

Pain Reliever - Aspirin (NSAID)

Caffeine Warning
  • the recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, irritability, sleeplessness, and occasionally rapid heart beat.

  • for occasional use only. Do not use for more than 2 days for a hangover unless directed by a doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to occur, consult a doctor.
Other Information
  • each tablet contains: sodium 406 mg
  • phenylketonurics: contains phenylalanine 12.6 mg per tablet

  • store at room temperature (59–86°F). Protect from excessive heat.

Active Ingredients

Aspirin 500 mg (NSAID*)

Caffeine 60 mg



*Nonsteroidal anti-inflammatory drug

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, aspartame, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Blowfish for Hangovers

Blowfish for Hangovers

Alertness Aid - Caffeine

Pain Reliever - Aspirin (NSAID)

12 effervescent tablets

Lemon Flavor

Blowfish for Headaches

20 effervescent tablets

Lemon Flavor

Alertness Aid - Caffeine

Pain Reliever - Aspirin (NSAID)

Questions Or Comments?

1-800-970-1793 (weekdays)

Ask A Doctor Before Use If
  • 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
  • you have a sodium-restricted diet
If Pregnant Or Breastfeeding

ask a health professional before use. It is especially important not to use aspiring during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 lasts for more than 10 days or gets worse

  • new symptoms occur

  • redness or swelling is present

  • ringing in the ears or a loss of hearing occurs

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Or Phamacist Before Use If You Are

taking a prescription drug for

  • diabetes
  • gout
  • arthritis


Structured Label Content

Uses
  • for the temporary relief of minor aches and pains associated with a hangover
  • helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness associated with a hangover
  • also for the temporary relief of headaches or body aches and pains alone

  • for the temporary relief of headache pain
  • also temporarily relieves minor aches and pains due to: backache muscle aches arthritis menstrual cramps hangover

  • for the temporary relief of muscle aches and pain
  • helps restore mental alertness when experiencing fatigue
Purpose

Aspirin…..Pain reliever



Caffeine…Alertness aid/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 Reyes syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Stomach bleeding warning:

This product contains a nonsteroidal anti-inflammatory drug (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
Directions
  • upon waking, fully dissolve 2 tablets in 16 oz. of water and drink
  • do not exceed recommended dosage
Adults and children 12 years and over

(up to 60 years of age)
2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 8 tablets in 24 hours
Adults 60 years and over 2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 4 tablets in 24 hours
Children under 12 years Do not use
Do Not Use (Do not use)
  • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever inducer
Blowfish Sport

Blowfish Sport

Caffeinated Pain Relief

20 effervescent tablets

Lemon Flavor

Alertness Aid - Caffeine

Pain Reliever - Aspirin (NSAID)

Caffeine Warning (Caffeine warning)
  • the recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, irritability, sleeplessness, and occasionally rapid heart beat.

  • for occasional use only. Do not use for more than 2 days for a hangover unless directed by a doctor. Not intended for use as a substitute for sleep. If fatigue or drowsiness persists or continues to occur, consult a doctor.
Other Information (Other information)
  • each tablet contains: sodium 406 mg
  • phenylketonurics: contains phenylalanine 12.6 mg per tablet

  • store at room temperature (59–86°F). Protect from excessive heat.

Active Ingredients (Active ingredients)

Aspirin 500 mg (NSAID*)

Caffeine 60 mg



*Nonsteroidal anti-inflammatory drug

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, aspartame, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Blowfish for Hangovers

Blowfish for Hangovers

Alertness Aid - Caffeine

Pain Reliever - Aspirin (NSAID)

12 effervescent tablets

Lemon Flavor

Blowfish for Headaches

20 effervescent tablets

Lemon Flavor

Alertness Aid - Caffeine

Pain Reliever - Aspirin (NSAID)

Questions Or Comments? (Questions or Comments?)

1-800-970-1793 (weekdays)

Ask A Doctor Before Use If (Ask a doctor before use if)
  • 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
  • you have a sodium-restricted diet
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use. It is especially important not to use aspiring during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

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 lasts for more than 10 days or gets worse

  • new symptoms occur

  • redness or swelling is present

  • ringing in the ears or a loss of hearing occurs

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Or Phamacist Before Use If You Are (Ask a doctor or phamacist before use if you are)

taking a prescription drug for

  • diabetes
  • gout
  • arthritis


Advanced Ingredient Data


Raw Label Data

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