FDA label d74cce29-359d-4e1d-9555-83a342d86999

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
5d3857b2-7579-44e4-84d1-24d72c0066b0
SPL ID
d74cce29-359d-4e1d-9555-83a342d86999
Version
1
Effective date
2010-07-02
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:56

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

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. 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 . Do not use: with any other products containing acetaminophen, (prescription or non-prescription). 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. Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea or vomiting, consult a doctor promptly. When using this product DO NOT EXCEED RECOMMENDED DOSAGE: taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage. Stop use and ask a doctor if: new symptoms occur fever gets worse or lasts more than 3 days pain gets worse or lasts more than 5 days redness or swelling is present. These could be signs of a serious condition. Keep out of reach of children. Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs or symptoms. Directions This product does not contain directions or complete warnings for adult use. Shake well before using. Find the right dose on the chart below. (If possible, use weight to dose; otherwise, use age.) Only use the enclosed dropper. Do not use any other dropper, spoon or dosing device when giving this medicine to your child. Fill the enclosed dropper to the prescribed level and slowly dispense the liquid into your child’s mouth (towards the inner cheek). If needed, repeat dose every 4 hours while symptoms last. Do not give more than 5 times in any 24-hour period (see overdose warning). Replace dropper tightly to maintain child resistance. Weight (Ibs) Age (yrs) Dose Under 24 Under 2 Ask a doctor 24-35 2-3 2.0 mL (1.0 mL + 1.0mL) 36-47 4-5 3.0 mL (1.0mL + 1.0 mL + 1.0mL)

warnings table

<table> <col width="91"/> <col width="78"/> <col width="126"/> <tbody> <tr> <td styleCode="Toprule Lrule Rrule " align="center">Weight (Ibs) </td> <td styleCode="Toprule Lrule Rrule " align="center">Age (yrs) </td> <td styleCode="Toprule Lrule Rrule " align="center">Dose </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " align="center">Under 24 </td> <td styleCode="Toprule Lrule Rrule " align="center">Under 2 </td> <td styleCode="Toprule Lrule Rrule " align="center">Ask a doctor </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " align="center">24-35 </td> <td styleCode="Toprule Lrule Rrule " align="center">2-3 </td> <td styleCode="Toprule Lrule Rrule " align="center">2.0 mL (1.0 mL + 1.0mL) </td> </tr> <tr> <td styleCode="Toprule Lrule Rrule " align="center">36-47 </td> <td styleCode="Toprule Lrule Rrule " align="center">4-5 </td> <td styleCode="Toprule Lrule Rrule " align="center">3.0 mL (1.0mL + 1.0 mL + 1.0mL) </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.