FDA label e63b2e15-539e-4a74-bb8b-dbe87e4dce59

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
1b85179c-846c-4f9c-ad66-26ab29e710b7
SPL ID
e63b2e15-539e-4a74-bb8b-dbe87e4dce59
Version
4
Effective date
2011-04-13
Source export date
2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:32:38

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 This product should be prescribed with caution in patients with persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or where cough is accompanied by excessive secretions. Advise patients to take medication a few hours before bedtime to minimize the possibility of sleeplessness. The medication should be taken with a glass of water after each dose, to help loosen mucus in the lungs. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes mellitus, narrow angle glaucoma or prostatic hypertrophy.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse effects associated with phenylephrine may include nervousness, restlessness, and headache. Adverse effects associated with antihistamines may include drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare. Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly. Dizziness, headache, and rash (including urticaria) have been reported rarely.

Reported adverse events (FAERS/openFDA)#

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