BLOWFISH- aspirin, caffeine tablet, effervescent

Blowfish by

Drug Labeling and Warnings

Blowfish by is a Otc medication manufactured, distributed, or labeled by Rally Labs LLC, Tower Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Aspirin 500 mg (NSAID*)
Caffeine 60 mg

*Nonsteroidal anti-inflammatory drug

Purpose

Aspirin…..Pain reliever

Caffeine…Alertness 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

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

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.

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 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

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

Blowfish for Hangovers

Alertness Aid - Caffeine

Pain Reliever - Aspirin (NSAID)
12 effervescent tablets

Lemon Flavor

12_Count_Box_Outside_Revised_12_27.jpg

IMAGE NAME IMAGE DELETE IMAGE REFERENCED
12_Count_Box_Outside_Revised_12_27.jpg [Delete Image] Yes
product--12Tablet.jpg

INGREDIENTS AND APPEARANCE

BLOWFISH 
aspirin, caffeine tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75920-0464
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	60 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75920-0464-1	2 in 1 BOX; Type 0: Not a Combination Product	07/23/2011
2	NDC: 75920-0464-8	12 in 1 BOX; Type 0: Not a Combination Product	07/23/2011
3	NDC: 75920-0464-2	20 in 1 BAG; Type 0: Not a Combination Product	11/30/2017
4	NDC: 75920-0464-4	40 in 1 BAG; Type 0: Not a Combination Product	11/30/2017
5	NDC: 75920-0464-6	4 in 1 BOX; Type 0: Not a Combination Product	02/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	07/23/2011

Labeler - Rally Labs LLC (965453108)

Establishment
Name	Address	ID/FEI	Business Operations
Tower Laboratories Ltd		001587203	manufacture(75920-0464)