NDC 78612-110 Splizz Pain Reliever - Orange-flavored

Acetaminophen, Aspirin, And Caffeine

NDC Product Code 78612-110

NDC CODE: 78612-110

Proprietary Name: Splizz Pain Reliever - Orange-flavored What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Aspirin, And Caffeine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
ORANGE (C48331 - LIGHT ORANGE)
Shape: ROUND (C48348)
Size(s):
25 MM
Imprint(s):
S
Score: 1
Flavor(s):
ORANGE (C73406)

NDC Code Structure

  • 78612 - Marga Labs, Llc
    • 78612-110 - Splizz Pain Reliever - Orange-flavored

NDC 78612-110-20

Package Description: 10 POUCH in 1 CARTON > 2 TABLET, EFFERVESCENT in 1 POUCH

NDC Product Information

Splizz Pain Reliever - Orange-flavored with NDC 78612-110 is a a human over the counter drug product labeled by Marga Labs, Llc. The generic name of Splizz Pain Reliever - Orange-flavored is acetaminophen, aspirin, and caffeine. The product's dosage form is tablet, effervescent and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 2474495.

Dosage Form: Tablet, Effervescent - A solid dosage form containing mixtures of acids (e.g., citric acid, tartaric acid) and sodium bicarbonate, which release carbon dioxide when dissolved in water; it is intended to be dissolved or dispersed in water before administration.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Splizz Pain Reliever - Orange-flavored Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • MANNITOL (UNII: 3OWL53L36A)
  • POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • ASPARTAME (UNII: Z0H242BBR1)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Marga Labs, Llc
Labeler Code: 78612
FDA Application Number: part343 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-01-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Splizz Pain Reliever - Orange-flavored Product Label Images

Splizz Pain Reliever - Orange-flavored Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

DISTRIBUTED BY MARGA LABS, LLCCINCINNATI, OHIO 45241

Otc - Purpose

Active ingredients (in each tablet)PurposeAcetaminophen 250mgPain relieverAspirin 250mg (NSAIDNonsteroidal anti-inflammatory drug)Pain relieverCaffeine 65mgPain reliever aid

Uses

  • Temporarily relieves minor aches and pains due to:headachea coldarthritisbackachemuscular achestoothachepremenstrual & 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 reddeningblistersrash.If a skin reaction occurs, stop use and seek medical help right away.

  • Aspirin may cause a severe allergic reaction which may include:hivesfacial swellingasthma (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 amountwith other drugs containing acetaminophen3 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 youare age 60 or olderhave had stomach ulcers or bleeding problemstake a blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have 3 or more alcoholic drinks every day while using this producttake 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 reducerwith 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 diseasestomach bleeding warning applies to youyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, or kidney diseaseyou are taking a diureticyou have asthmayou have a sodium-restricted diet

Ask A Doctor Or Pharmacist Before Use If You Are Taking

  • A prescription drug for diabetes, gout, or arthritisany 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 faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betterringing in the ears or loss of hearing occurspainful area is red or swollenpain gets worse or lasts for more than 10 daysfever get worse or lasts for more than 3 daysany 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 directedFully dissolve 2 tablets in a glass of water and drinkAdults 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 mgstore at room temperature (59°-86°F)Read all product information before using.

Inactive Ingredients

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

* Please review the disclaimer below.