Storage and handling
Other information each 5ml contains: sodium 2mg store between 20-25°C (68-77°F)
Other information each 5ml contains: sodium 2mg store between 20-25°C (68-77°F)
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Usestemporarily:
- reduces fever
- relieves minor aches and pains due to:
Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:
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
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
When using this product, do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning:In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Do not take more than directed.
See overdose warning
DOSING CHART
| Weight (lbs) | Age (yr) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
*or as directed by a doctor
Attention:use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device
Other information
Inactive ingredientsanhydrous citric acid, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum
Questions or comments?Call 1-877-290-4008
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 2 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 2 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 2 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 2 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 2 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51316-643-04 | Dye Free Infants Pain and Fever | 1 in 1 BOX | SUSPENSION | 1 | 2 | |
| 51316-643-04 | Dye Free Infants Pain and Fever | 60 mL in 1 BOTTLE | SUSPENSION | 60 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51316-643 | 51316-643-04 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Dye Free Infants Pain and Fever | ACETAMINOPHEN | CVS | 1fde0f7c-4b5b-ae9c-e063-6394a90afa41 | 2025-02-13 | Warnings | 51316-643-04 51316-643 51316064304 2e04cbea-f8fc-77f6-e063-6394a90a45af 1fde0f7c-4b5b-ae9c-e063-6394a90afa41 |
Adverse event summaries are temporarily unavailable. Other product information remains available.