Indications and uses
Temporarily relieves common cold and flu symptoms: nasal congestion cough due to minor throat and bronchial irritation headache minor aches and pains fever sore throat
Temporarily relieves common cold and flu symptoms: nasal congestion cough due to minor throat and bronchial irritation headache minor aches and pains fever sore throat
take only as directed do not exceed 4 doses per 24 hours adults and children 12 years and over take 2 softgels with water every 4 hours children 4 to under 12 years ask a doctor children under 4 years do not use
store at room temperature
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Temporarily relieves common cold and flu symptoms:
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:
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
When using this product, do not use more than directed.
Stop use and ask a doctor if
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
| adults and children 12 years and over | take 2 softgels with water every 4 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, polysorbate, povidone, propylene glycol, purified water,
sorbitol sorbitan solution, titanium dioxide.
call toll-free 1-800-630-8895
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80513-301-50 | DAYTIME COLD AND FLU RELIEF SOFTGELSNON-DROWSY | 50 in 1 BOTTLE | CAPSULE, GELATIN COATED | 50 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80513-301 | DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE) CAPSULE, GELATIN COATED [ADVANCED RX LLC] | 5 | Current NDC, 1 package rows | 20240918_fa1a4d86-87bb-0c50-e053-6394a90a56e2.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 80513-301 | 80513-301-50 |
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 |
|---|---|---|---|---|---|---|
| DAYTIME COLD AND FLU RELIEF SOFTGELS NON-DROWSY | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE | Advanced Rx LLC | fa1a4d86-87bb-0c50-e053-6394a90a56e2 | 2024-09-13 | Warnings | 80513-301-50 80513-301 80513030150 220d0f73-1573-686b-e063-6394a90a9a50 fa1a4d86-87bb-0c50-e053-6394a90a56e2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.