FDA label 3f9df124-44ad-a8a5-e063-6294a90a1549

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
4c06b5cf-036d-4bbd-b055-a07bf2015beb
SPL ID
3f9df124-44ad-a8a5-e063-6294a90a1549
Version
4
Effective date
2025-09-25
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:27:02

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 to sedate a child or to make a child sleepy if you are now 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Directions measure only with dosing cup provided keep dosing cup with product mL = milliliter do not take more than 4 doses in any 24-hour period age dose Children under 6 years do not use children 6 to under 12 years 10 mL every 6 hours adults and children 12 years and older 20 mL every 6 hours Other information each 10 mL contains: sodium 7 mg store at room temperature. Do not refrigerate.

warnings table

<table width="100%"><col width="49%"/><col width="51%"/><thead><tr><th align="center" styleCode="Botrule Lrule Toprule " valign="bottom"><content styleCode="bold">age</content></th><th align="center" styleCode="Rrule Botrule Toprule " valign="bottom"><content styleCode="bold">dose</content></th></tr></thead><tbody><tr><td align="center" styleCode="Lrule Toprule Botrule " valign="top"><paragraph>Children under 6 years</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="top"><paragraph>do not use</paragraph></td></tr><tr><td align="center" styleCode="Lrule Botrule " valign="top"><paragraph>children 6 to under 12 years</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>10 mL every 6 hours</paragraph></td></tr><tr><td align="center" styleCode="Botrule Lrule " valign="top"><paragraph>adults and children 12 years and older</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>20 mL every 6 hours</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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