FDA label f567bdb0-60ac-4ab1-b1ec-f20b8726a3a1

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
f2113abf-c1a3-42a6-a25e-e30a31fcad95
SPL ID
f567bdb0-60ac-4ab1-b1ec-f20b8726a3a1
Version
3
Effective date
2024-09-12
Source export date
2026-10-22
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-22/63b92dadbf6487b575e111b437d26dfb89c1d6401bf1507c742074f4503ba64d/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
5de9d3c3492926d1703b492ae4d29b036ac5be73edfcb92a6cd5eb95a2acef9c
Import run
20261023T001338Z
Imported at
2026-10-23 00:19:13

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 DAYTIME in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certan 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 childs prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. NIGHTTIME in a child under 4 years of age with any other product containing diphenhydramine even one used on the skin for the purpose of making your child sleepy Ask a doctor before use your child has DAYTIME cough that occurs with too much phlegm (mucus) persistent or chronic cough such occurs with asthma NIGHTTIME glaucoma cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occur with smoking, asthma, or emphysema a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if the child is NIGHTTIME taking sedatives or tranquilizers. When using this product Nighttime do not exceed recommended dosage marked drowsiness may occur excitability may occur, especially in children alcohol, sedatives and tranquilizers may increase the drowsiness effect avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if DAYTIME cough lasts more than 7 days, comes back, or occurs with a fever, rash, or headache that lasts.These could be signs of a serious condition. NIGHTTIME cough persists for more than 1 weeks, tend to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Daytime In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Nighttime In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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