Sinus Severe
- Product NDC
- 83324-115
- 11-digit product format
- 833240115
- Labeler code
- 83324
- Product ID
- 83324-115_1f194386-d218-f0ac-e063-6394a90ad5e9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- CHAIN DRUG MARKETING ASSOCIATION, INC.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-06
- 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
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| 495W7451VQ | GUAIFENESIN | 93-14-1 | GUAIFENESIN |
| 04JA59TNSJ | PHENYLEPHRINE HYDROCHLORIDE | 61-76-7 | PHENYLEPHRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83324-115-24 | 83324011524 | 2 BLISTER PACK in 1 CARTON (83324-115-24) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2024-08-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| 1119-QCH-2024-0806 | CHAIN DRUG MARKETING ASSOCIATION, INC. | 2024-08-07 | HUMAN OTC DRUG LABEL | 2 |