Blowfish Tablet, Effervescent
FDA Label NDC 75920-0464

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rally Labs Llc for the product Blowfish (NDC 75920-0464). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or phamacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Aspirin 500 mg (NSAID*)
Caffeine 60 mg

*Nonsteroidal anti-inflammatory drug

Purpose

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

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

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

Do Not Use

  • if you have ever had an allergic reaction to aspirin or any other pain reliever/fever inducer
  • in children under 12 years of age

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

Ask A Doctor Or Phamacist Before Use If You Are

taking a prescription drug for

  • diabetes
  • gout

  • arthritis

When Using This Product

  • 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.

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

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.

Keep Out Of Reach Of Children

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

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 over2 tablets every 6 hours, as needed, or as directed by a doctor. Do not exceed 4 tablets in 24 hours
    Children under 12 yearsDo not use

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.

Inactive Ingredients

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

Questions Or Comments?

1-800-970-1793 (weekdays)

Principal Display Panel

NEW!

PAIN RELIEVER • ALERTNESS AID

Contains Aspirin (NSAID) and Caffeine

Blowfish ®

for Hangovers

12 EFFERVESCENT TABLETS

P/N: 6039A R: 01/12

DO NOT USE IF PRINTED PACKETS ARE TORN OR PUNCTURED

Own the night.
Save the day.

WAKE up with a hangover.
DROP Blowfish in water.
DRINK when fizzing stops.
FORGET your hangover.

Distributed by Rally Labs LLC
P.O. Box 20094, New York, NY 10014
1-800-970-1793

P/N: 6040A R: 01/12

* Please review the disclaimer below.