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
- 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
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 | c64075e9-1ff9-4dc9-b6b5-85e66d902654 | id | |
| spl set id | 61998119-9948-46a1-98c0-e020bb658151 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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
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.