Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain
- Product NDC
- 63824-241
- 11-digit product format
- 638240241
- Labeler code
- 63824
- Product ID
- 63824-241_51a49072-914b-892d-e063-6294a90a641f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-03-01
- Substance
- ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 200; 5 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1243679 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2ef9d5de-e99e-4398-bf97-c7bef94498fa | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 63824-241-20 | 2020-10-09 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-44 | 2020-10-09 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-72 | 2020-10-09 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-20 | 2020-09-27 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-44 | 2020-09-27 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-72 | 2020-09-27 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-20 | 2020-09-25 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-44 | 2020-09-25 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-72 | 2020-09-25 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-20 | 2020-07-22 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-44 | 2020-07-22 | Mucinex® Sinus-Max® Severe Congestion and Pain |
| 63824-241-72 | 2020-07-22 | Mucinex® Sinus-Max® Severe Congestion and Pain |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63824-241-10 | Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 8 | |
| 63824-241-10 | Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 8 | |
| 63824-241-20 | Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 8 | |
| 63824-241-20 | Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | 8 | |
| 63824-241-44 | Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 8 | |
| 63824-241-44 | Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | 4 in 1 CARTON | TABLET, FILM COATED | 4 | 8 | |
| 63824-241-72 | Maximum Strength Mucinex Sinus-Max Severe Congestion and Pain | 2 in 1 POUCH | TABLET, FILM COATED | 2 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63824-241 | MAXIMUM STRENGTH MUCINEX SINUS-MAX SEVERE CONGESTION AND PAIN (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [RB HEALTH (US) LLC] | 7 | Current NDC, Legacy NDC, 7 package rows | 20241220_2ef9d5de-e99e-4398-bf97-c7bef94498fa.zip |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | bd97e91f-1ae1-379c-e053-2995a90acfdd | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | a6a2dd4a-a3c8-2dfa-e053-2995a90ada86 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | bd49121c-7cba-c51f-e053-2995a90a921e | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare, LLC. | a6b8dc25-0fb9-1823-e053-2a95a90adf93 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | c2232241-6e57-1427-e053-2995a90a488a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51dec468-fbb2-3489-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | d7711cd6-5058-548d-e053-2a95a90ac54d | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | a2f0285b-8550-fd26-e053-2995a90ab615 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | f6c73f61-f4fc-377f-e053-6294a90a3797 | 2025-12-04 | Warnings | M012 |
| Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Bayer Healthcare LLC. | a32e2a5e-9aa0-4e7c-e053-2995a90a3190 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | e2877488-3539-cba2-e053-2995a90a6005 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cough and Sore Throat FizzyChews | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 14951faa-9476-6f29-e063-6394a90a14c7 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels | ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION | Bayer HealthCare LLC. | 0c120569-622d-3a23-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Flu FizzyChews | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 149330be-24bd-b4a4-e063-6394a90a9007 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN | Bayer HealthCare LLC. | 5278a128-41ec-4494-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 53188c41-3f13-311b-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 75894849-a0ba-57be-e053-2a91aa0a049a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 531ab703-179a-70ad-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 7588ea67-68a9-4dc0-e053-2991aa0aa471 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Cough | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 75862805-2cfe-fb45-e053-2991aa0a1403 | 2025-12-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1243679 | acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | 2ef9d5de-e99e-4398-bf97-c7bef94498fa | 8 |
| 1243679 | acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 2ef9d5de-e99e-4398-bf97-c7bef94498fa | 8 |
| 1243679 | APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 2ef9d5de-e99e-4398-bf97-c7bef94498fa | 8 |
| 1243679 | APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet | SY | 2ef9d5de-e99e-4398-bf97-c7bef94498fa | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63824-241-10 | 63824024110 | 1 BLISTER PACK in 1 CARTON (63824-241-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2021-07-12 | 0000-00-00 | No | No | Current |
| 63824-241-20 | 63824024120 | 2 BLISTER PACK in 1 CARTON (63824-241-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2018-03-30 | 0000-00-00 | No | No | Current |
| 63824-241-44 | 63824024144 | 4 POUCH in 1 CARTON (63824-241-44) / 2 TABLET, FILM COATED in 1 POUCH | 4 pouch | 2018-03-30 | 0000-00-00 | No | No | Current |
| 63824-241-72 | 63824024172 | 2 TABLET, FILM COATED in 1 POUCH (63824-241-72) | 2018-03-30 | 0000-00-00 | No | No | Current |