Label: SPLIZZ PAIN RELIEVER - GRAPEFRUIT-FLAVORED- acetaminophen, aspirin, and caffeine tablet, effervescent

  • 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 January 25, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet)Purpose
    *
    Nonsteroidal anti-inflammatory drug
    Acetaminophen 250mgPain reliever
    Aspirin 250mg (NSAID*)Pain reliever
    Caffeine 65mgPain reliever aid
  • Uses

    Temporarily relieves minor aches and pains due to:

    • headache
    • a cold
    • arthritis
    • backache
    • muscular aches
    • toothache
    • premenstrual & menstrual cramps
  • 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 Reye's syndrome, a rare but serious illness.

    Allergy alert

    Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash. If a skin reaction occurs, stop use and seek medical help right away.

    Allergy alert

    Aspirin may cause a severe allergic reaction which may include:

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

    Liver warning

    This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4000 mg in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Stomach bleeding warning

    This product contains an 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 nonprescription 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.

    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 while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

    Do Not Use

    • if you ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer
    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

    Ask a doctor before use if

    • you have liver disease
    • 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 pharmacist before use if you are taking

    • a prescription drug for diabetes, gout, or arthritis
    • any other drug, or are under a doctor's care for any serious condition

    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
    • ringing in the ears or loss of hearing occurs
    • painful area is red or swollen
    • pain gets worse or lasts for more than 10 days
    • fever get worse or lasts for more than 3 days
    • any new symptoms occur. These could be signs of a serious condition.

    If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin 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

    • do not use more than directed
    • Fully dissolve 2 tablets in a glass of water and drink
    • Adults and children 12 years and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours.
    • Children under 12 years: do not use.
  • Other information

    • each tablet contains: sodium 416 mg
    • Phenylketonurics: contains phenylalanine 11 mg per tablet
    • store at room temperature (59°-86°F)
    • Read all product information before using.
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, aspartame, D&C red # 28 aluminum lake, docusate sodium, FD&C red # 40, flavors, leucine, magnesium citrate, mannitol, povidone, sodium benzoate, sodium bicarbonate

  • Questions or comments?

    Call 1-888-707-3713

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY MARGA LABS, LLC
    CINCINNATI, OHIO 45241

  • PRINCIPAL DISPLAY PANEL - 20 Tablet Pouch Carton

    EXTRA STRENGTH

    splizz

    Fast Pain Reliever

    Acetaminophen,
    Aspirin (NSAID) &
    Caffeine

    Pain Reliever | Pain Reliever Aid

    Red Grapefruit

    20 Effervescent Tablets

    PRINCIPAL DISPLAY PANEL - 20 Tablet Pouch Carton
  • INGREDIENTS AND APPEARANCE
    SPLIZZ PAIN RELIEVER - GRAPEFRUIT-FLAVORED 
    acetaminophen, aspirin, and caffeine tablet, effervescent
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78612-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen250 mg
    Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin250 mg
    Caffeine (UNII: 3G6A5W338E) (Caffeine - UNII:3G6A5W338E) Caffeine65 mg
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium bicarbonate (UNII: 8MDF5V39QO)  
    Mannitol (UNII: 3OWL53L36A)  
    Povidone, Unspecified (UNII: FZ989GH94E)  
    Acesulfame potassium (UNII: 23OV73Q5G9)  
    Aspartame (UNII: Z0H242BBR1)  
    Product Characteristics
    ColorPINK (Light pink) Scoreno score
    ShapeROUND (Round pressed tablet) Size25mm
    FlavorGRAPEFRUITImprint Code S
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78612-100-2010 in 1 CARTON01/21/2021
    12 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34301/21/2021
    Labeler - Marga Labs, LLC (105847280)