Storage and handling
Other information store at room temperature
Other information store at room temperature
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
Warnings
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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
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 right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
take only as directed
do not exceed 4 doses per 24 hrs
Other information
Inactive ingredients FD&C blue #1, D&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water,
shellac, sorbitol sorbitan solution, titanium dioxide.
Questions? Call 1-877-290-4008
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 5 |
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| DOXYLAMINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-976-24 | NIGHTIME COLD AND FLU | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 5 | |
| 11673-976-24 | NIGHTIME COLD AND FLU | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11673-976 | 11673-976-24 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| WATER | 059QF0KO0R | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| SORBITOL | 506T60A25R | IACT |
| POVIDONE | FZ989GH94E | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| NIGHTIME COLD AND FLU | NIGHTIME COLD AND FLU | TARGET CORP | 9dee9b92-eac9-b07d-e053-2995a90a0602 | 2025-01-31 | Warnings | 11673-976-24 11673-976 11673097624 2d0e13ab-d4ec-f0cb-e063-6294a90a37c3 9dee9b92-eac9-b07d-e053-2995a90a0602 |
Adverse event summaries are temporarily unavailable. Other product information remains available.