FDA label 3f0f622a-4390-4e0a-892b-08c572be59f5

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
35f6edb5-923c-4bf7-ab23-31bad90448ac
SPL ID
3f0f622a-4390-4e0a-892b-08c572be59f5
Version
3
Effective date
2021-01-29
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:30:39

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. • Do not use if printed seal under cap is torn or missing

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.