FDA label c7ba2caf-ed17-4171-b900-4d3e0155cdc4

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
37c6ebc3-55fe-4158-a5d6-05c5b4bb5f50
SPL ID
c7ba2caf-ed17-4171-b900-4d3e0155cdc4
Version
1
Effective date
2013-02-06
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:05:29

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

Ask a doctor before use if the child has a cough that occurs with too much phlegm (mucus) or persistant or chronic cough such as occurs with asthma. Directions may be given every 4 hours do not use more than 6 times in 24 hours use only enclosed dosing cup to dose this product. Do not use any other dosing device. Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. 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) TSP = teaspoon under 4 yrs. ask a doctor 4 to under 6 ½ TSP to 1 TSP 6 to under 12 1 TSP to 2 TSP or as directed by a doctor 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="50%"> <col width="50%" align="center" valign="top"/> <col width="50%" align="center" valign="top"/> <thead> <tr> <th styleCode="Lrule Rrule">Age (yr)</th> <th styleCode="Rrule">Dose (TSP)</th> </tr> </thead> <tfoot> <tr> <td align="left" valign="top" colspan="2">TSP = teaspoon</td> </tr> </tfoot> <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">&#xBD; TSP to 1 TSP</td> </tr> <tr styleCode="Botrule"> <td styleCode="Lrule Rrule">6 to under 12</td> <td styleCode="Rrule">1 TSP to 2 TSP</td> </tr> <tr> <td styleCode="Lrule Rrule" colspan="2">or as directed by a doctor</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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