Indications and uses
For the temporary relief of minor aches and pains associated with: • the common cold • flu • sore throat • headache • toothache • and to reduce fever
Acetaminophen
- Manufacturer
- Oncor Pharmaceuticals
- Effective date
- 2026-06-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- daily-update
- Hydrated at
- 2026-07-15 00:33:02
Label at a glance#
ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections
Dosage and administration
this product does not contain directions or complete warnings for adult use Use only the enclosed dosing cup designed for use with this product. if possible, use weight to dose, otherwise use age. dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor. Weight (lbs.) Age (years) Dosage Teaspoonful (tsp)* Under 24 Under 2 Consult a doctor 24 to 35 2 to u...
Storage and handling
Each 5 mL contains: Sodium 3 mg If dispensed, dispense in a tight, light resistant container with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each 5 mL teaspoonful)
Acetaminophen, USP 160 mg
Purpose
Pain reliever/Fever reducer
Uses
For the temporary relief of minor aches and pains associated with:
• the common cold
• flu
• sore throat
• headache
• toothache
• and to reduce fever
Warnings:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
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.
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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 your child has liver disease.
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Stop use and ask a doctor if• pain gets worse or lasts more than 5 days
- pain gets worse or lasts more than 5 day.
- fever gets worse or lasts more than 3 days
- redness or swelling is present.
- any new symotom appear.
These could be signs of a serious condition.
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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- this product does not contain directions or complete warnings for adult use
- Use only the enclosed dosing cup designed for use with this product.
- if possible, use weight to dose, otherwise use age.
- dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor.
Weight (lbs.) | Age (years) | Dosage Teaspoonful (tsp)* |
| Under 24 | Under 2 | Consult a doctor |
| 24 to 35 | 2 to under 4 | 5 mL (1 tsp) |
| 36 to 47 | 4 to under 6 | 7.5 mL (1 1/2 tsp) |
| 48 to 59 | 6 to under 9 | 10 mL (2 tsp) |
| 60 to 71 | 9 to under 11 | 12.5 mL (2 1/2 tsp) |
| 72 to 95 | 11 to under 12 | 15 mL (3 tsp) |
* or as directed by a doctor
Other information
- Each 5 mL contains: Sodium 3 mg
- If dispensed, dispense in a tight, light resistant container with a child-resistant cap.
- Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)
Inactive ingredients
Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, Sucralose.
Questions?
You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.
SPL UNCLASSIFIED SECTION
Tamper-Evident:
Do not use if foil seal over bottle opening is torn, broken, or missing.
SPL UNCLASSIFIED SECTION
Manufactured In USA For :
Oncor Pharmaceuticals
6755 Business Pkwy Suite 202
Elkridge, MD 21075
United States.
Rev. 01/2024
PRINCIPAL DISPLAY PANEL
ONCOR PHARMACEUTICALS
NDC 83720- 500-16
Pain and
Fever Relief
kids
Acetaminophen
Liquid 160 mg / 5 mL
Alcohol Free
Sugar Free
Aspirin Free
Ibuprofen Free
Cherry Flavor
16 fl. oz. - 473 mL
ONCOR PHARMACEUTICALS
NDC 83720- 500-16
Pain and
Fever Relief
kids
Acetaminophen
Liquid 160 mg / 5 mL
Alcohol Free
Sugar Free
Aspirin Free
Ibuprofen Free
Cherry Flavor
4 fl. oz. - 118 mL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0383720500167 | GTIN-13: 0383720500167 EAN-13: 0383720500167 GTIN-12: 383720500167 UPC-A: 383720500167 GTIN storage (14 digits): 00383720500167 | Acetaminophen liquid 160 mg (16 oz).jpg |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83720-500-16 | ML - Milliliter | 83720-500 | 889f8864-a053-4775-ad9a-8509a43186e4 | 1 | 2024-05-16 |
Products#
Every source-derived product name is available through these pages.
- Acetaminophen
- CITRIC ACID MONOHYDRATE
- FD&C RED NO. 40
- POLYETHYLENE GLYCOL, UNSPECIFIED
- WATER
- SORBITOL
- SODIUM BENZOATE
- SODIUM CITRATE, UNSPECIFIED FORM
- SACCHARIN SODIUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83720-500 | 83720-500-16, 83720-500-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2025-04-28 | full-release | 2026-06-01 00:59:51 |
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 |
|---|---|---|---|---|---|---|
| Acetaminophen | ACETAMINOPHEN | Oncor Pharmaceuticals | 4c396d0e-aa93-4f9e-b065-2e606f7f05cd | 2026-06-17 | Warnings | 83720-500-04 83720-500-16 83720-500 83720050004 83720050016 54776532-fc43-798b-e063-6394a90aeda0 4c396d0e-aa93-4f9e-b065-2e606f7f05cd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.