FDA label c64075e9-1ff9-4dc9-b6b5-85e66d902654

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
61998119-9948-46a1-98c0-e020bb658151
SPL ID
c64075e9-1ff9-4dc9-b6b5-85e66d902654
Version
2
Effective date
2010-12-27
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 01:29:56

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 the recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor. Do not take this product if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor. Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, heart disease, peripheral vascular disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor. Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, should not take this product unless directed by a doctor. May cause or aggravate constipation. Pseudoephedrine & Codeine Liquid should be taken a few hours prior to bedtime to minimize the possibility of sleeplessness. Pseudoephedrine is banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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

adverse reactions

ADVERSE REACTIONS The most common adverse reactions to Pseudoephedrine & Codeine Liquid include nausea, cardiac palpitations, increased irritability or excitement, headache, dizziness, tachycardia, diarrhea, drowsiness, stomach pain, seizures, slowed heart rate, shortness of breath, and/or troubled breathing. Cardiovascular System: Cardiac arrhythmia, increased heart rate, increased blood pressure. Dermatologic: Urticaria, drug rash, photosensitivity, and pruritus. Central Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. Genitourinary: Urinary frequency, difficult urination, urinary retention, early menses. Respiratory: Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.

Reported adverse events (FAERS/openFDA)#

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