Head Congestion and Flu Severe
- Product NDC
- 50844-000
- Requested package NDC
- 50844-000-09
- 11-digit product format
- 508440000
- Labeler code
- 50844
- Product ID
- 50844-000_a046c578-ebf8-4cd1-a153-23d41b8f7e39
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2021-05-05
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325 mg/1; mg/1; mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50844-000-09 | 50844000009 | 2 BLISTER PACK in 1 CARTON (50844-000-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2021-05-05 | 0000-00-00 | No | No | Current |