FDA label 22772b94-6bde-17fd-e063-6294a90aed1b

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
eee190e9-0698-44bf-9399-eb1450378af5
SPL ID
22772b94-6bde-17fd-e063-6294a90aed1b
Version
2
Effective date
2024-09-19
Source export date
2026-08-01
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/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:03:52

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 use Nighttime 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 with any other product containing diphenhydramine, even one used on skin. Daytime to sedate a child or to make 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 Nighttime heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that last as occurs with smoking, asthma, chronic bronchitis or emphysema Daytime heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged gland cough that occurs with too much phlegm (mucus) a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema Ask a doctor or pharmacist before use if you are Nighttime taking any other oral nasal decongestant or stimulant taking sedative or tranquilizers Daytime taking any other oral nasal decongestant or stimulant taking sedative or tranquilizers When using these products Nighttime do not use more than directed may cause marked drowsiness 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 Daytime do not use more than directed may cause marked drowsiness avoid alcoholic drinks alcohol, sedative 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 Nighttime nervousness, dizziness or sleeplessness occurs symptoms do not get better within 7 days or accompanied by fever 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 Daytime nervousness, dizziness or sleeplessness occur symptoms do not improve within 7 days or are accompanied by fever 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, Nighttime ask a health professional before use. Daytime ask a health professional before use Keep out of reach of children. Nighttime In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Daytime In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.