Indications and uses
For the temporary relief of symptoms due to the common cold/ flu: runny nose sneezing nasal congestion minor aches and pain headache and temporarily reduces fever
For the temporary relief of symptoms due to the common cold/ flu: runny nose sneezing nasal congestion minor aches and pain headache 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: ask a doctor
| Active ingredients (in each tablet) | Purposes |
| Acetaminophen 325 mg................... | Pain reliever/ fever reducer |
| Chlorpheniramine maleate 2 mg ........... | Antihistamine |
| 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
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: ask a doctor
acesulfame potassium, anhydrous citric acid, FD&C red #40, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, strawberry flavor, 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 |
|---|---|
| 55758-408 | 55758-408-36 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| WATER | 059QF0KO0R | IACT |
| ACESULFAME POTASSIUM | 23OV73Q5G9 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DIMETHICONE | 92RU3N3Y1O | IACT |
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 |
|---|---|---|---|---|---|---|
| 25b2c5be-8542-bc4a-e063-6394a90ab107 | 1ad172fb-d4b2-e28c-e063-6294a90a751f | 2024-10-30 | Warnings | 1ad172fb-d4b2-e28c-e063-6294a90a751f |
Adverse event summaries are temporarily unavailable. Other product information remains available.