OTC - ACTIVE INGREDIENT SECTION
Active ingredient (per 5 mL teaspoonful)
Acetaminophen 160 mg
Liquid Acetaminophen
- Manufacturer
- LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
- Effective date
- 2025-12-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- full-release
- Hydrated at
- 2026-06-01 01:30:29
Label at a glance#
ProductLiquid Acetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose
Pain Reliever/Fever Reducer
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual and menstrual cramps
- temporarily reduces fever
WARNINGS SECTION
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:
- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday 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.
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.
Ask a doctor before use if you have liver disease.
Ask a doctor before use if you are taking the blood thinning drug warfarin.
When using this product: Do not exceed recommended dose.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days in adults
- pain gets worse or lasts more than 5 days in children under 12 years
- 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 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 Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.
DOSAGE & ADMINISTRATION SECTION
Directions
- do not take more than directed
- find dose in chart below
- if possible, use weight to dose, otherwise use age
- dosage may be repeasted every 4 hours, or as directed by a doctor
- do not give more than 5 doses in 24 hours
| Weight (lbs) | under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 | over 95 |
| Age (years) | under 2 | 2 to 3 | 4 to 5 | 6 to 8 | 9 to 10 | 11 | 12 to adult |
| Dosage Teaspoonful (tsp) | consult Physician | 1 tsp (5 mL) | 1 1/2 tsp (7.5 mL) | 2 tsp (10 mL) | 2 1/2 tsp (12.5 mL) | 3 tsp (15 mL) | 4 tsp (20 mL) |
INACTIVE INGREDIENT SECTION
Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307675 | acetaminophen 160 MG in 5 mL Oral Solution | PSN | 6 |
| 307675 | acetaminophen 32 MG/ML Oral Solution | SCD | 6 |
| 307675 | acetaminophen 160 MG per 5 ML Oral Solution | SY | 6 |
| 307675 | acetaminophen 325 MG per 10.15 ML Oral Solution | SY | 6 |
| 307675 | acetaminophen 650 MG per 20.3 ML Oral Solution | SY | 6 |
| 307675 | acetaminophen 80 MG per 2.5 ML Oral Solution | SY | 6 |
| 307675 | APAP 32 MG/ML Oral Solution | SY | 6 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54859-809-16 | Liquid Acetaminophen | 473 mL in 1 BOTTLE | LIQUID | 473 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54859-809-16 | ML - Milliliter | 54859-809 | a7cc10e7-86b4-485c-901e-bc571c0f4d11 | 1 | 2020-01-03 |
Products#
Every source-derived product name is available through these pages.
- Liquid Acetaminophen
- Acetaminophen
- ANHYDROUS CITRIC ACID
- FD&C RED NO. 40
- METHYLPARABEN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54859-809 | 54859-809-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | 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 |
|---|---|---|---|---|---|---|
| Liquid Acetaminophen | ACETAMINOPHEN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | a7dbd4c0-53eb-4368-917b-1432c09ce6b4 | 2025-12-31 | Warnings | 54859-809-16 54859-809 54859080916 47461076-1bb2-ffd6-e063-6294a90a5885 a7dbd4c0-53eb-4368-917b-1432c09ce6b4 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.