FDA Label for Splizz Pain Reliever - Grapefruit-flavored

Other

Drug Facts

DISTRIBUTED BY MARGA LABS, LLC
CINCINNATI, OHIO 45241

Otc - Purpose

Uses

Temporarily relieves minor aches and pains due to:

• headache
• a cold
• arthritis
• backache
• muscular aches
• toothache
• premenstrual & menstrual cramps

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.

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.
  
  

Otc - Pregnancy Or Breast Feeding

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.

Otc - Keep Out Of Reach Of Children

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

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 - grapefruit 01