BLOWFISH- aspirin, caffeine tablet, effervescent

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Aspirin 500 mg (NSAID*) Caffeine 60 mg *Nonsteroidal anti-inflammatory drug
Available from:
Rally Labs LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Aspirin…..Pain reliever Caffeine…Alertness aid/Pain reliever aid - 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 - if you have ever had an allergic reaction to aspirin or any other pain reliever/fever inducer - 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 taking a prescription drug for - diabetes - gout - arthritis arthritis - 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  you experience an
Authorization status:
OTC monograph not final
Authorization number:
75920-0464-1, 75920-0464-2, 75920-0464-4, 75920-0464-6, 75920-0464-8

BLOWFISH- aspirin, caffeine tablet, effervescent

Rally Labs LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredients

Aspirin 500 mg (NSAID*)

Caffeine 60 mg

*Nonsteroidal anti-inflammatory drug

Purpos e

Aspirin…..Pain reliever

Caffeine…Alertness aid/Pain reliever aid

Us es

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

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product--12Tablet.jpg

BLOWFISH

aspirin, caffeine tablet, effervescent

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:759 20 -0 46 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

50 0 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 0 mg

Rally Labs LLC

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

ASPARTAME (UNII: Z0 H242BBR1)

DO CUSATE SO DIUM (UNII: F0 5Q2T2JA0 )

MANNITO L (UNII: 3OWL53L36 A)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM BICARBO NATE (UNII: 8 MDF5V39 QO)

Product Characteristics

Color

white

S core

no sco re

S hap e

ROUND

S iz e

25mm

Flavor

LEMON

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:759 20 -0 46 4-1

2 in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 7/23/20 11

2

NDC:759 20 -0 46 4-8

12 in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 7/23/20 11

3

NDC:759 20 -0 46 4-2

20 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

11/30 /20 17

4

NDC:759 20 -0 46 4-4

40 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

11/30 /20 17

5

NDC:759 20 -0 46 4-6

4 in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 2/0 1/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 7/23/20 11

Labeler -

Rally Labs LLC (965453108)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

To wer Labo rato ries Ltd

0 0 158 720 3

ma nufa c ture (759 20 -0 46 4)

Revised: 1/2020

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