Indications and uses
For the temporary relief of symptoms due to the common cold/ flu: runny nose sneezing nasal congestion cough due to minor throat and bronchial irritation minor aches and pain headache sore throat and temporarily reduces fever
For the temporary relief of symptoms due to the common cold/ flu: runny nose sneezing nasal congestion cough due to minor throat and bronchial irritation minor aches and pain headache sore throat and temporarily reduces fever
■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours, or as directed by a doctor. ■ children under 12 years of age: do not use
| Active ingredients (in each tablet) | Purposes |
| Acetaminophen 325 mg................... | Pain reliever/ fever reducer |
| Chlorpheniramine maleate 2 mg ....... | Antihistamine |
| Dextromethorphan HBr 10 mg ........... | Cough suppressant |
| Phenylephrine HCl 5 mg ..................... | Nasal decongestant |
For the temporary relief of symptoms due to the common cold/ flu:
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash. If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
ask a health professional before use.
In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours, or as directed by a doctor.
■ children under 12 years of age: do not use
acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, grape flavor, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, sucralose, water
+1-866-359-3478 (M-F) 9 AM to 5 PM EST or
www.pharmadel.com
Pharmadel LLC.
New Castle, DE 19720
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55758-446 | 55758-446-36 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 25a0f3d4-81f3-a013-e063-6394a90a8a77 | 201f1a11-876d-bc6f-e063-6394a90aa918 | 2024-10-29 | Warnings | 201f1a11-876d-bc6f-e063-6394a90aa918 |
Adverse event summaries are temporarily unavailable. Other product information remains available.