FDA label 059489a1-9595-4471-ad24-7c04780100eb

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
021b7fe8-802d-44d1-a525-54e7c4e783b0
SPL ID
059489a1-9595-4471-ad24-7c04780100eb
Version
2
Effective date
2018-12-10
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:21:00

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 the child takes more than 5 doses in 24 hours, which is the maximum daily amount. with other drugs containing acetaminophen. Do not use with any other product containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. 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 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 reach of children. Overdose warning: Thaking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a poison control center right away. Quick 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 dose do not give more than directed (see overdose warning) find right dose on chart below. If possible, use weight to dose; otherwise, use age. dissolve in mouth, or chew before swallowing if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor. Weight (lb) Age (yr) Tablets under 48 lbs under 6 years ask a doctor 48-59 lbs 6-8 years 2 60-71 lbs 9-10 years 2 1/2 72-95 lbs 11 years 3 Other information store at controlled room temperature betweeen 20-25 o C(68-77 o F) see end flap for expiration date and lot number Inactive ingredients acesulfame pottasium, citric acid, D&C red 27 aluminum lake, dextrose, FD&C blue 1 aluminum lake, flavors, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose powder, polyplasdone, sorbitol, sucralose. May contain ethylcellulose, gelatin, sodium polyphosphate, silicon dioxide.

warnings table

<table width="557px"> <caption/> <tbody> <tr> <td> Weight (lb)</td> <td> Age (yr)</td> <td> Tablets</td> </tr> <tr> <td> under 48 lbs</td> <td> under 6 years</td> <td> ask a doctor</td> </tr> <tr> <td> 48-59 lbs</td> <td> 6-8 years</td> <td> 2</td> </tr> <tr> <td> 60-71 lbs</td> <td> 9-10 years</td> <td> 2 1/2</td> </tr> <tr> <td> 72-95 lbs</td> <td> 11 years</td> <td> 3</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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