Alka-seltzer Plus Day Severe Cold Plus Flu Powder, For Solution
NDC Package 0280-0921-06
Package Information
Alka-seltzer Plus Day Severe Cold Plus Flu (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride) powders is do not take more than the recommended dosetake every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctoradults and children 12 years and over: dissolve contents of one packet in 8 oz. This formulation utilizes a powder, for solution delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-0921 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1550968 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Powder for Oral Solution
- RxCUI: 1550968 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
- RxCUI: 1550968 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Granules for Oral Solution
- RxCUI: 1550968 - APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Guaifenesin 400 MG / Phenylephrine Hydrochloride 10 MG Powder for Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 0280 - Bayer Healthcare Llc.
- 0280-0921 - Alka-seltzer Plus Day Severe Cold Plus Flu
- 0280-0921-06 - 6 PACKET in 1 CARTON / 1 POWDER, FOR SOLUTION in 1 PACKET
- 0280-0921 - Alka-seltzer Plus Day Severe Cold Plus Flu
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0280-0921-06 identifies a specific commercial package of 6 packet in 1 carton / 1 powder, for solution in 1 packet of Alka-seltzer Plus Day Severe Cold Plus Flu, a human over the counter drug labeled by Bayer Healthcare Llc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 6 billable units per package. This powder, for solution is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bayer Healthcare Llc. on April 17, 2014. The current certification is valid through December 31, 2027.
How is this Bayer Healthcare Llc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00280092106. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.