Label: BLOWFISH- aspirin, caffeine tablet, effervescent
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NDC Code(s):
75920-0464-1,
75920-0464-2,
75920-0464-4,
75920-0464-5, view more75920-0464-6, 75920-0464-7, 75920-0464-8
- Packager: Rally Labs LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated December 20, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
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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
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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
- Ask a doctor before use if
- Ask a doctor or phamacist before use if you are
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Caffeine warning
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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.
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Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
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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
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pain lasts for more than 10 days or gets worse
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new symptoms occur
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redness or swelling is present
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ringing in the ears or a loss of hearing occurs
- If pregnant or breastfeeding
- Keep out of reach of children
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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
- Inactive ingredients
- Questions or Comments?
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Blowfish for Hangovers
Blowfish for Hangovers
Alertness Aid - Caffeine
Pain Reliever - Aspirin (NSAID)
12 effervescent tabletsLemon Flavor
12_Count_Box_Outside_Revised_12_27.jpg
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INGREDIENTS AND APPEARANCE
BLOWFISH
aspirin, caffeine tablet, effervescentProduct 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 6 NDC:75920-0464-5 20 in 1 BOX; Type 0: Not a Combination Product 12/28/2020 7 NDC:75920-0464-7 20 in 1 BOX; Type 0: Not a Combination Product 12/28/2020 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)