FDA label 88296153-9cb6-4d91-9758-de36bced4673

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
5fe26cb7-4aa6-4bfe-a9ec-d1af33fa6965
SPL ID
88296153-9cb6-4d91-9758-de36bced4673
Version
3
Effective date
2012-03-27
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:48

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 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. Do not take this product, unless directed by a doctor before use if you have a persistent or chronic cough such as occurs with smoking, asthma or emphysema a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma a cough that occurs with too much phlegm (mucus) heart disease, diabetes, high blood pressure or thyroid disease difficulty in urination due to enlargement of the prostate gland. Ask a doctor before use if you are taking sedatives or tranquilizers. When using the product may cause marked drowsiness alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic beverages be careful when driving a motor vehicle or operating machinery may cause excitability especially in children. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occurs symptoms do not improve within 7 days or are accompanied by a fever cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. If pregnant or breastfeeding, ask a health professional before use. Keep this and other drugs out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Pseudoephedrine is banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Reported adverse events (FAERS/openFDA)#

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