FDA label 4f9c124d-ad7d-4482-8fec-23048e6452ba

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
29d01244-7724-427c-ab1a-26227bb8f3dd
SPL ID
4f9c124d-ad7d-4482-8fec-23048e6452ba
Version
2
Effective date
2015-05-04
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:32:47

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 ■ taken with other drugs containing acetaminophen 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/Pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems Stop Use and ask a doctor if ■ symptoms do not improve ■ pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days ■ new symptoms occur ■ redness or swelling is present ■ a rare sensitivity reaction occurs ■ You may report side effects to 1-888-952-0050 Keep Out of Reach of Children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. 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 ■ chew tablets before swallowing ■ all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period ■ follow the chart below for proper dosing or as directed by a doctor ■ if possible, use weight for dosing, otherwise use age. Weight (lbs) Under 24 24-35 36-47 48-59 60-71 72-95 Age (yrs) Under 2 2-3 4-5 6-8 9-10 11 Tablets Consult a doctor 2 3 4 5 6 Other information ■ Phenylketonurics: contains phenylalanine 2.8 mg per tablet ■ store at room temperature ■ protect from excessive moisture ■ do not use if imprinted safety seal under cap is broken or missing Inactive ingredients aspartame, croscarmellose sodium, D&C red #7, flavors, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose.

warnings table

<table ID="inv-009bca68-bad3-40e6-8896-62419f2377d0" frame="border" border="1"> <col width="88px"/> <col width="88px"/> <col width="88px"/> <col width="88px"/> <col width="88px"/> <col width="88px"/> <col width="88px"/> <thead valign="bottom"> <tr valign="bottom"> <td valign="bottom" styleCode="Botrule Lrule Rrule Toprule">Weight (lbs)</td> <td valign="bottom" styleCode="Botrule Rrule Toprule">Under 24</td> <td valign="bottom" styleCode="Botrule Rrule Toprule">24-35</td> <td valign="bottom" styleCode="Botrule Rrule Toprule">36-47</td> <td valign="bottom" styleCode="Botrule Rrule Toprule">48-59</td> <td valign="bottom" styleCode="Botrule Rrule Toprule">60-71</td> <td valign="bottom" styleCode="Botrule Rrule Toprule">72-95</td> </tr> </thead> <tbody> <tr> <td styleCode="Botrule Lrule Rrule"> Age (yrs)</td> <td styleCode="Botrule Rrule"> Under 2</td> <td styleCode="Botrule Rrule"> 2-3</td> <td styleCode="Botrule Rrule"> 4-5</td> <td styleCode="Botrule Rrule"> 6-8</td> <td styleCode="Botrule Rrule"> 9-10</td> <td styleCode="Botrule Rrule"> 11</td> </tr> <tr> <td styleCode="Botrule Lrule Rrule"> Tablets</td> <td styleCode="Botrule Rrule">Consult a doctor</td> <td styleCode="Botrule Rrule"> 2</td> <td styleCode="Botrule Rrule"> 3</td> <td styleCode="Botrule Rrule"> 4</td> <td styleCode="Botrule Rrule"> 5</td> <td styleCode="Botrule Rrule"> 6</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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