FDA label 49239617-90b7-4a48-9d8b-e24c6d112231
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
- SPL set ID
- 00f66f25-3469-4c16-9baf-fba21e9628bd
- SPL ID
- 49239617-90b7-4a48-9d8b-e24c6d112231
- Version
- 2
- Effective date
- 2011-04-26
- Source export date
- 2026-10-12
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:50:17
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 49239617-90b7-4a48-9d8b-e24c6d112231 | id | |
| spl set id | 00f66f25-3469-4c16-9baf-fba21e9628bd | set_id |
Boxed warning cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
TAMPER-EVIDENT FEATURE: DO NOT USE IF SAFETY SEAL IMPRINTED WITH “TRIAMINIC” AROUND BOTTLE CAP IS BROKEN OR MISSING.
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
Warnings Do not use • in a child under 4 years of age • in a child who is 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 the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. • with any other product containing diphenhydramine, even one used on skin • for the purpose of making your child sleepy Ask a doctor before use if the child has • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • chronic cough that lasts, or as occurs with asthma • a breathing problem such as chronic bronchitis Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers. When using this product • do not exceed recommended dosage • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children Stop use and ask a doctor if • nervousness, dizziness or sleeplessness occurs • symptoms do not improve within 7 days or occur with a fever • cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.