FDA label 64a827ee-facd-684a-e053-2a91aa0ad447

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
fe74017b-3387-4e72-9e2d-9eb46465c3df
SPL ID
64a827ee-facd-684a-e053-2a91aa0ad447
Version
2
Effective date
2018-02-07
Source export date
2026-08-08
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/2026-08-08/2ef638b6b5a68e854d11a3945e1b1aa8d0e7f812a9d69af10df01eecf2e189d0/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 18:03:57

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not exceed recommended dosage. Do not use this product <ul> <li>do not use this with any product containing diphenhydramine, even one used on skil</li> <li>if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depresion, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug.&nbsp; If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.<br /> &nbsp;</li> </ul> Ask a doctor before use if you have <ul> <li>a breathing problem such as emphysema or chronic bronchitis especially in children</li> <li>glaucoma</li> <li>trouble urinating due to an enlarged prostate gland</li> <li>heart disease</li> <li>high blood pressure</li> <li>thyroid disease</li> <li>diabetes mellitus<br /> &nbsp;</li> </ul> Ask a doctor or pharmacist before use if you are <p>now taking sedatives or tranquilizers.<br /> &nbsp;</p> When using this product <ul> <li>may cause excitability especially in children</li> <li>may cause marked drowsiness</li> <li>avoid alcoholic drinks</li> <li>alcohol, sedatives, and tranquilizers may increase drowsiness</li> <li>be careful when driving a motor vehicle or operating machinery<br /> &nbsp;</li> </ul> Stop use and ask a doctor if <ul> <li>nervousness, dizziness, or sleeplessness occur</li> <li>cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache.&nbsp; These could be signs of serious condition</li> <li>new symptoms occur<br /> &nbsp;</li> </ul> If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. <p>In case of accidental overdose seek professional help or contact a Poison Control Center immediately.<br /> &nbsp;</p>