Otc - Active Ingredient
Active Ingredient
in each 15 mL Tablespoonful
Acetaminophen 500 mg
Purgenlabs Acetaminophen Liquid
FDA Label NDC 80513-230
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Llc for the product Purgenlabs Acetaminophen (NDC 80513-230). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Pain Reliever/Fever Reducer
Indications & Usage
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Warnings
Liver Warning:This product contains acetaminophen. The maximurr
daily dose of fhis product is 6 tablespoonfuls in 24 hours.
Severe liver damage may occur if you take
• more than 8 tablespoonfuls (4,000 mg of acetaminophen) in 24
hours • with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
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.
Otc - Do Not Use
Do not use • with any other drug containing acetaminophen
(prescription or nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a octor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive
ingredients in this product
Ask a doctor before use ff rou have liver disease.
Ask a doctor before use ff you are taking the blood thinning
drug wartarin.
When using this product Do not exceed recommended dose.
Otc - Stop Use
Stop use and ask a doctor If • pain gets worse or lasts more than
10 days • fever gets worse or lasts more than 3 days • new
symptoms occur • redness or swelling is present.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
| Age | Dose |
| adults and children 12 years of age and older | Take 1 to 2 Tablespoonfuls every 4 to 6 hours as needed; not more than 6 tablespoonsfuls in 24 hours |
| children under 12 years | Do not use |
Inactive Ingredient
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
Otc - Questions
Questions or comments? call toll free 1-800-630-8895
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