Puregen Labs Acetaminophen

Manufacturer
Advanced Rx LLC
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:30:14

Label at a glance#

ProductPuregen Labs Acetaminophen
Active ingredientACETAMINOPHEN
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Pain Relever/Fever Reducer

INDICATIONS & USAGE SECTION

USES

  • temporarily relieves minor aches and pains due to
  • headache
  • toothache
  • muscular aches
  • the common cold
  • backache
  • minor pain from arthritis
  • premenstrual and menstrual cramps
  • temporarily reduces fever

WARNINGS SECTION

Warnings

Liver Warning: This product contains acetaminophen. The maxium daily dose of this product is 90 mL in 24 hours. Severe liver damage may occur if you take

  • more than 120 ml (4,000 mg of acetaminophen) in 24 hours
  • with other drusg containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause 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 SECTION

Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have liver disease.

Ask a doctor before use if you are taking the blood thinning drug warafin

When using this product: Do not exceed recommeneded dose.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever get 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 SECTION

If pregnant or breast-feeding, ask a health professional before use

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not take more than directed
AgeDose
Adults and children 12 years of age and olderTake 1 to 2 tablespoonfuls every 4 to 6 hours as needed. Not more than 6 tablespoonfuls in 24 hours
Children under 12 yearsdo not use

INACTIVE INGREDIENT SECTION

Inactive ingredients: artificail and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

OTC - QUESTIONS SECTION

Questions or comments? 1-800-630-8895

RECENT MAJOR CHANGES SECTION

Fix typos

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PuregenAPAPPuregenAPAP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN1
307684acetaminophen 33.3 MG/ML Oral SolutionSCD1
307684APAP 1000 MG per 30 ML Oral SolutionSY1
307684APAP 167 MG per 5 ML Oral SolutionSY1
307684APAP 33.3 MG/ML Oral SolutionSY1
307684APAP 500 MG per 15 ML Oral SolutionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130380513001139GTIN-13: 0380513001139
EAN-13: 0380513001139
GTIN-12: 380513001139
UPC-A: 380513001139
GTIN storage (14 digits): 00380513001139
PuregenAPAP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80513-001-13Puregen Labs Acetaminophen237 mL in 1 BOTTLELIQUID2371

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
80513-00180513-001-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
Puregen Labs AcetaminophenACETAMINOPHENAdvanced Rx LLC474580af-f6b0-e440-e063-6394a90aaada2025-12-31WarningsExact identifier
ndc (package): 80513-001-13
ndc (product): 80513-001
ndc11 (package): 80513000113
spl id: 474580a4-7e34-16bc-e063-6394a90a927d
spl set id: 474580af-f6b0-e440-e063-6394a90aaada

Reported adverse events (FAERS/openFDA)#

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