Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax Kit
NDC Package 0280-0035-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, phenylephrine hydrochloride) kits is directions· do not take more than the recommended dose· do not take the Day and Night products at the same time; wait 4 hoursafter the last Night dose before starting Day product· adults and children 12 years and over: take 2 capsules with waterevery 4 hours. This formulation utilizes a kit delivery system. Marketed by Bayer Healthcare Llc., this product is identified by NDC 0280-0035 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0280-0035-01
Package Description
1 KIT in 1 CARTON * 3 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 3 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Product Code
0280-0035
11-Digit Billing Format
00280003501
RxNorm Crosswalk
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1297288 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule
  • RxCUI: 1297288 - APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule
  • RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule
  • RxCUI: 1656815 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule

Clinical Specifications

Proprietary Name
Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, Phenylephrine Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
Directions· do not take more than the recommended dose· do not take the Day and Night products at the same time; wait 4 hoursafter the last Night dose before starting Day product· adults and children 12 years and over: take 2 capsules with waterevery 4 hours. Do not exceed 6 capsules in 12 hours or asdirected by a doctor.· children under 12 years: do not use Directions· do not take more than the recommended dose· do not take the Day and Night products at the same time; wait 4 hours after the last Day dose before starting Night product· adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not exceed 4 capsules in 12 hours or as directed by a doctor.· children under 12 years: do not use

Regulatory & Marketing

Labeler Name
Bayer Healthcare Llc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 0280-0035-01 identifies a specific commercial package of 1 kit in 1 carton * 3 capsule, liquid filled in 1 blister pack * 3 capsule, liquid filled in 1 blister pack of Alka-seltzer Plus Cough, Mucus And Congestion Day And Night Powermax, a human over the counter drug labeled by Bayer Healthcare Llc.. This kit is formulated for oral use and contains 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 June 01, 2020. 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: 00280003501. 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:

10-Digit Format (4-4-2)
0280-0035-01
11-Digit CMS (5-4-2)
00280-0035-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.