Alka-seltzer Plus Severe Sinus Cold And Cough Capsule, Liquid Filled
NDC Package 0280-0507-20
Package Information
Alka-seltzer Plus Severe Sinus Cold And Cough (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) capsules is do not take more than the recommended doseadults and children 12 years and over: take 2 capsules with water every 4 hours. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-0507 and is authorized under FDA application M013.
Identification & Billing
- RxCUI: 1432488 - acetaminophen 250 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule
- RxCUI: 1432488 - acetaminophen 250 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule
- RxCUI: 1432488 - APAP 250 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
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.
- 0280-0507 - Alka-seltzer Plus Severe Sinus Cold And Cough
- 0280-0507-20 - 2 BLISTER PACK in 1 CARTON / 20 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
- 0280-0507 - Alka-seltzer Plus Severe Sinus Cold And Cough
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 0280-0507-20 identifies a specific commercial package of 2 blister pack in 1 carton / 20 capsule, liquid filled in 1 blister pack of Alka-seltzer Plus Severe Sinus Cold And Cough Liquid Gels, 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 2 billable units per package. This capsule, liquid filled 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 January 28, 2015. The current certification is valid through December 31, 2026.
How is this Bayer Healthcare Llc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00280050720. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 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.