Indications and uses
temporarily: reduces fever relieves minor aches and pain due to: the common cold flu headache sore throat toothache
temporarily: reduces fever relieves minor aches and pain due to: the common cold flu headache sore throat toothache
this product does not contain directions or complete warnings for adult use do not take more than directed (see overdose warning) shake well before using mL = milliliter find the right dose on chart below. If possible, use weight to dose; otherwise, use age repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lbs) Age (yr) Dose (mL) or as directed by a doctor Under 24 Und...
each 5 mL contains: sodium 2 mg Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] protect from freezing a red, berry flavored suspension supplied in the following oral dosage form: NDC 0121-1781-05: 5 mL unit dose cup, in a tray of ten cups
Acetaminophen 160 mg
Pain reliever/fever reducer
temporarily:
Liver warning: This product contains 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.
• if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
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 the recommended dose (see overdose warning)
Stop use and ask a doctor if:
• pain gets worse or lasts more than 5 days
• 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.
Keep out of the 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 children even if you do not notice any sign or symptoms
| Weight (lbs) | Age (yr) | Dose (mL) * |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 years | 5 mL |
| 36-47 | 4-5 years | 7.5 mL |
| 48-59 | 6-8 years | 10 mL |
| 60-71 | 9-10 years | 12.5 mL |
| 72-95 | 11 years | 15 mL |
* or as directed by a doctor
NDC 0121-1781-05: 5 mL unit dose cup, in a tray of ten cups
Acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
Call 1-800-845-8210.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 307668 | acetaminophen 160 MG in 5 mL Oral Suspension | PSN | 13 |
| 307668 | acetaminophen 32 MG/ML Oral Suspension | SCD | 13 |
| 307668 | acetaminophen 160 MG per 5 ML Oral Suspension | SY | 13 |
| 307668 | acetaminophen 320 MG per 10 ML Oral Suspension | SY | 13 |
| 307668 | acetaminophen 650 MG per 20.3 ML Oral Suspension | SY | 13 |
| 307668 | acetaminophen 80 MG per 2.5 ML Oral Suspension | SY | 13 |
| 307668 | APAP 32 MG/ML Oral Suspension | SY | 13 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0121-1781-00 | 2021-08-23 | C162847 | 48780-1 | ba0f9c33-13ad-a910-e053-dadaa90a0b85 | Children's Acetaminophen Oral Suspension Ibuprofen Free/Alcohol Free/Aspirin Free |
| 0121-1781-00 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-13ad-a910-e053-dadaa90a0b85 | Children's Acetaminophen Oral Suspension Ibuprofen Free/Alcohol Free/Aspirin Free |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0121-1781-00 | Childrens Acetaminophen | 10 in 1 CASE | SUSPENSION | 10 | 13 | |
| 0121-1781-00 | Childrens Acetaminophen | 10 in 1 TRAY | SUSPENSION | 10 | 13 | |
| 0121-1781-05 | Childrens Acetaminophen | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 13 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-1781-00 | ML - Milliliter | 0121-1781 | 216b7a39-3839-44f8-ba3a-cf40c8056029 | 1 | 2017-06-15 |
| 0121-1781-05 | ML - Milliliter | 0121-1781 | 9246f12e-a346-4cc7-95b3-f112f0c76851 | 1 | 2015-02-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0121-1781 | 0121-1781-05, 0121-1781-00 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | 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 |
|---|---|---|---|---|---|---|
| Childrens Acetaminophen | ACETAMINOPHEN | PAI Holdings, LLC dba PAI Pharma | 46d9d8cd-e3db-492c-9386-7e8255beff64 | 2024-10-08 | Warnings | 0121-1781-05 0121-1781-00 0121-1781 00121178105 00121178100 5c063866-c8c4-4be2-abad-d09d279fc99f 46d9d8cd-e3db-492c-9386-7e8255beff64 |
Adverse event summaries are temporarily unavailable. Other product information remains available.