Splizz Pain Reliever - Orange-flavored Tablets

Manufacturer
Marga Labs, LLC
Effective date
2021-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:37:08

Label at a glance#

ProductSplizz Pain Reliever - Orange-flavored
Active ingredientAcetaminophen, Aspirin, Caffeine
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains due to: headache a cold arthritis backache muscular aches toothache premenstrual & menstrual cramps

Dosage and administration

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.

Storage and handling

each tablet contains: sodium 416 mg store at room temperature (59°-86°F) Read all product information before using.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Acetaminophen 250mgPain reliever
Aspirin 250mg (NSAID*)Pain reliever
Caffeine 65mgPain reliever aid

* Nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains due to:

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

Warnings

WARNINGS SECTION

Reye's syndrome

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Aspirin may cause a severe allergic reaction which may include:

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

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - STOP USE SECTION

  • 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 SECTION

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 SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, docusate sodium, FD&C yellow #6 aluminum lake, flavors, leucine, magnesium citrate, mannitol, povidone, sodium benzoate, sodium bicarbonate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-707-3713

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY MARGA LABS, LLC
CINCINNATI, OHIO 45241

PRINCIPAL DISPLAY PANEL - 20 Tablet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

splizz

Fast Pain Reliever

Acetaminophen,
Aspirin (NSAID) &
Caffeine

Pain Reliever | Pain Reliever Aid

Orange

20 Effervescent Tablets

PRINCIPAL DISPLAY PANEL - 20 Tablet Pouch Carton
PRINCIPAL DISPLAY PANEL - 20 Tablet Pouch Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2474495acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Effervescent Oral TabletPSN1
2474495acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Effervescent Oral TabletSCD1
2474495APAP 250 MG / ASA 250 MG / caffeine 65 MG Effervescent Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
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41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
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816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78612-110-202023-01-30C16284748780-1f386c64a-2151-0266-e053-dadaa90a7c1aSplizz Pain Reliever - Orange-flavored Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78612-110-20Splizz Pain Reliever - Orange-flavored2 in 1 POUCHTABLET, EFFERVESCENT21
78612-110-20Splizz Pain Reliever - Orange-flavored10 in 1 CARTONTABLET, EFFERVESCENT101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78612-110SPLIZZ PAIN RELIEVER - ORANGE-FLAVORED (ACETAMINOPHEN, ASPIRIN, AND CAFFEINE) TABLET, EFFERVESCENT [MARGA LABS, LLC]1Legacy NDC, 2 package rows20210121_94e126c4-8987-400d-bd63-4e5993db4bf9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78612-11078612-110-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f966aea6-d108-4f68-9f20-d1c827f8617194e126c4-8987-400d-bd63-4e5993db4bf92021-01-15WarningsExact identifier
spl id: f966aea6-d108-4f68-9f20-d1c827f86171
spl set id: 94e126c4-8987-400d-bd63-4e5993db4bf9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.