FDA label 97558c3c-84f5-4185-8462-a113bd2e3be8

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
e9e021cf-b8eb-4309-bf0b-a24334ba278e
SPL ID
97558c3c-84f5-4185-8462-a113bd2e3be8
Version
1
Effective date
2013-02-06
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 02:21:26

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 Do not use in a child under 4 years of age in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if the child has heart disease high blood pressure thyroid disease diabetes cough that occurs with too much phlegm (mucus) chronic cough that lasts, or as occurs with asthma. When using this product do not exceed recommended dosage. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs. symptoms do not improve within 7 days or occur with a fever. cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition. Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product. Age (yr) Dose (TSP) under 4 yrs. ask a doctor 4 to under 6 1 TSP 6 to under 12 2 TSP or as directed by a doctor TSP = teaspoon Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In the 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.

warnings table

<table width="40%" styleCode="Noautorules"> <col width="45%" align="center" valign="middle"/> <col width="55%" align="center" valign="middle"/> <thead> <tr styleCode="Toprule Botrule"> <th styleCode="Lrule Rrule">Age (yr)</th> <th styleCode="Rrule">Dose (TSP)</th> </tr> </thead> <tbody> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">under 4 yrs.</td> <td styleCode="Rrule">ask a doctor</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">4 to under 6</td> <td styleCode="Rrule">1 TSP</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">6 to under 12</td> <td styleCode="Rrule">2 TSP</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule" colspan="2" align="center">or as directed by a doctor</td> </tr> <tr> <td colspan="2" align="center" valign="bottom">TSP = teaspoon</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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