SPLIZZ PAIN RELIEVER - GRAPEFRUIT-FLAVORED- acetaminophen, aspirin, and caffeine tablet, effervescent 
Marga 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.

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Splizz Pain Reliever - Grapefruit-flavored Tablets

Drug Facts

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:

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

Other information

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

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
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)

Revised: 1/2021
Document Id: 3f74053a-87e3-438d-a891-6af86a567a20
Set id: f678f5c6-2dcd-46a1-84a2-b4522fccf1eb
Version: 1
Effective Time: 20210125
 
Marga Labs, LLC