Storage and handling
Other information store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Other information store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Acetaminophen, USP 325 mg
Dextromethorphan HBr, USP 15 mg
Doxylamine Succinate, USP 6.25 mg
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Uses
Warnings
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.
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.
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. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
| age | dose |
|---|---|
adults and children 12 years and over | 2 capsules every 6 hours |
children under 12 years | do not use |
Other information
Inactive ingredients
D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
Questions or comments?
Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675
Distributed by: Pfizer, Madison, NJ 07940 USA
ADULT
Robitussin ®
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
DEXTROMETHORPHAN HBr (Cough Suppressant)
DOXYLAMINE SUCCINATE (Antihistamine)
CF
NIGHTTIME
MAX
For Ages 12 & Over
10
LIQUID-FILLED
CAPSULES

| 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 |
|---|---|---|---|---|---|---|
| 0031-8744-10 | Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | 5 in 1 CARTON | CAPSULE, LIQUID FILLED | 5 | 5 | |
| 0031-8744-10 | Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | 2 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 2 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0031-8744 | ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM 7 IN 1 RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240408_e7cf7c5d-5c9a-4201-9e30-1cd616071855.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0031-8744 | 0031-8744-10 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| DOXYLAMINE SUCCINATE | V9BI9B5YI2 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | e7cf7c5d-5c9a-4201-9e30-1cd616071855 | 2024-04-06 | Warnings | 0031-8744-10 0031-8744 00031874410 156fd078-37b4-ddce-e063-6294a90ae226 e7cf7c5d-5c9a-4201-9e30-1cd616071855 |
Adverse event summaries are temporarily unavailable. Other product information remains available.