Indications and uses
Temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
Temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache
this product does not contain directions or complete warnings for adult use mL=mililiter find right dose on chart below. If possible, use weight to dose; otherwise, use age. fill to dose level. Do not use any other dosing device dispense liquid slowly into child's mouth, toward inner cheek repeat dose every 4 hours while symptoms last rinse the dosing device after each use do not give more than 5 times in 24 hour...
Acetaminophen 160mg
Fever reducer/ pain reliever
Temporarily:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
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.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
liver disease
taking the blood thinning drug warfarin
(See overdose warning)
These could be signs of a serious condition
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Weight (lb) | Age (year) | Dose (mL)* |
| Under 24 | Under 2 years | Ask a doctor |
| 24-35 | 2-3 | 5mL |
* 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.
Acesulfame Potassium, Avicel, Butyl paraben, citric acid, FD&C Red #33, FD&C Blue #1, Glycerin, High fructose corn syrup, Nat grape flavor, polysorbate 80, propylene glycol, sodium benzoate, sorbitol, sucralose, Prosweet N and A, Purified water, xanthan gum
Call 1-844-832-1138
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69517-628-17 | 2023-10-22 | C162847 | 48780-1 | 9d75b9d0-187f-f424-e053-dadaa90a57ce | Infant's Acetaminophen Oral Suspension Pain Reliever/ Fever Reducer |
| 69517-628-17 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-187f-f424-e053-dadaa90a57ce | Infant's Acetaminophen Oral Suspension Pain Reliever/ Fever Reducer |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69517-628 | 69517-628-17 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| WATER | 059QF0KO0R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
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 |
|---|---|---|---|---|---|---|
| 0846cb11-4b42-53af-e063-6294a90a351a | 3cea7d70-acdb-44c8-abf5-d18e17d4f6be | 2023-10-21 | Warnings | 3cea7d70-acdb-44c8-abf5-d18e17d4f6be |
Adverse event summaries are temporarily unavailable. Other product information remains available.