FDA label 7d7b7231-891d-4354-9842-2c223bb3a14f

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
8df32c19-06f3-4ec5-89a2-68ac958a6d04
SPL ID
7d7b7231-891d-4354-9842-2c223bb3a14f
Version
2
Effective date
2017-07-26
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:03:24

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if:  Symptoms persist for more than 7 days or worsen  Inflammation, fever or infection develops  Symptoms are accompanied by high fever (101°F)  Cough tends to recur or is accompanied by high fever, rash or persistent headache Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222. Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional. A persistent cough may be a sign of a serious condition. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. There have been no reports of interactions between this product and Ibuprofen or acetaminophen.

warnings

Warnings As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if: • Symptoms persist for more than 7 days or worsen • Inflammation, fever or infection develops • Symptoms are accompanied by high fever (101°F) • Cough tends to recur or is accompanied by high fever, rash or persistent headache Keep this and all medications out of the reach of children . In case of accidental overdose, contact a medical professional or Poison Control Center immediately at 1-800-222-1222. Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed medical professional. A persistent cough may be a sign of a serious condition. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. There have been no reports of interactions between this product and Ibuprofen or acetaminophen. Directions  Measure only with the dosing cup provided  Do not use dosing cup with other products  mL = milliliter Children 2 years to under 6 years 5 mL at bedtime and every 4 hours during the night or as necessary Children 6 years to under 12 years 10 mL at bedtime and every 4 hours during the night or as necessary Adults and children 12 years and over 15 mL at bedtime and every 4 hours during the night or as necessary Other Information o Store at room temperature o Do not use if printed seal under cap is broken or missing

warnings table

<table width="100%"> <col width="50%"/> <col width="50%"/> <tbody> <tr> <td styleCode="Toprule "> <paragraph>Children 2 years to under 6 years</paragraph> </td> <td styleCode="Toprule "> <paragraph>5 mL at bedtime and every 4 hours during the night or as necessary</paragraph> </td> </tr> <tr> <td> <paragraph>Children 6 years to under 12 years</paragraph> </td> <td> <paragraph>10 mL at bedtime and every 4 hours during the night or as necessary </paragraph> </td> </tr> <tr> <td styleCode="Botrule "> <paragraph>Adults and children 12 years and over</paragraph> </td> <td styleCode="Botrule "> <paragraph>15 mL at bedtime and every 4 hours during the night or as necessary </paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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