Other
Drug Facts
DISTRIBUTED BY MARGA LABS, LLC
CINCINNATI, OHIO 45241
The following Structured Product Label (SPL) was submitted to the FDA by Marga Labs, Llc for the product Splizz Pain Reliever - Orange-flavored (NDC 78612-110). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, reye's syndrome, allergy alert, liver warning, stomach bleeding warning, caffeine warning, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
DISTRIBUTED BY MARGA LABS, LLC
CINCINNATI, OHIO 45241
| Active ingredients (in each tablet) | Purpose |
|---|---|
| Acetaminophen 250mg | Pain reliever |
| Aspirin 250mg (NSAID Nonsteroidal anti-inflammatory drug ) | Pain reliever |
| Caffeine 65mg | Pain reliever aid |
Temporarily relieves minor aches and pains due to:
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.
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
This product contains acetaminophen. Severe liver damage may occur if you take:
This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
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.
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.
anhydrous citric acid, docusate sodium, FD&C yellow #6 aluminum lake, flavors, leucine, magnesium citrate, mannitol, povidone, sodium benzoate, sodium bicarbonate, sucralose
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