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#
Contacts and useful links#
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
| 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 tablespoonfuls in 24 hours |
| Children under 12 years | do 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
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307684 | acetaminophen 500 MG in 15 mL Oral Solution | PSN | 1 |
| 307684 | acetaminophen 33.3 MG/ML Oral Solution | SCD | 1 |
| 307684 | APAP 1000 MG per 30 ML Oral Solution | SY | 1 |
| 307684 | APAP 167 MG per 5 ML Oral Solution | SY | 1 |
| 307684 | APAP 33.3 MG/ML Oral Solution | SY | 1 |
| 307684 | APAP 500 MG per 15 ML Oral Solution | SY | 1 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0380513001139 | GTIN-13: 0380513001139 EAN-13: 0380513001139 GTIN-12: 380513001139 UPC-A: 380513001139 GTIN storage (14 digits): 00380513001139 | PuregenAPAP.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-001-13 | Puregen Labs Acetaminophen | 237 mL in 1 BOTTLE | LIQUID | 237 | 1 |
Products#
Every source-derived product name is available through these pages.
- Puregen Labs Acetaminophen
- Acetaminophen
- SODIUM CITRATE
- METHYLPARABEN
- FD&C RED NO. 40
- PROPYLPARABEN
- CITRIC ACID
- WATER
- SUCRALOSE
- PROPYLENE GLYCOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80513-001 | 80513-001-13 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| CITRIC ACID | 2968PHW8QP | IACT |
| WATER | 059QF0KO0R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Puregen Labs Acetaminophen | ACETAMINOPHEN | Advanced Rx LLC | 474580af-f6b0-e440-e063-6394a90aaada | 2025-12-31 | Warnings | 80513-001-13 80513-001 80513000113 474580a4-7e34-16bc-e063-6394a90a927d 474580af-f6b0-e440-e063-6394a90aaada |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
