Flo Pms Complete Tablet
NDC Package 83049-489-08

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

Package Information

Flo Pms Complete (acetaminophen, caffeine, pyrilamine maleate) tablets is • do not take more than the recommended dose• adults and children 12 years and over:   • take 2 caplets with water   • repeat every 6 hours, as needed   • do not exceed 6 caplets per day• children under 12 years: ask a doctor. This formulation utilizes a tablet delivery system. Marketed by O Positiv, Inc., this product is identified by NDC 83049-489 and is authorized under FDA application M013.

Identification & Billing

NDC Package Code
83049-489-08
Package Description
3 BLISTER PACK in 1 CARTON / 8 TABLET in 1 BLISTER PACK
Product Code
83049-489
11-Digit Billing Format
83049048908
RxNorm Crosswalk
  • RxCUI: 1597298 - acetaminophen 500 MG / caffeine 60 MG / pyrilamine maleate 15 MG Oral Tablet
  • RxCUI: 1597298 - APAP 500 MG / Caffeine 60 MG / Pyrilamine Maleate 15 MG Oral Tablet

Clinical Specifications

Proprietary Name
Flo Pms Complete
Non-Proprietary Name
Acetaminophen, Caffeine, Pyrilamine Maleate
Substance Name
Acetaminophen; Caffeine; Pyrilamine Maleate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
• do not take more than the recommended dose• adults and children 12 years and over:   • take 2 caplets with water   • repeat every 6 hours, as needed   • do not exceed 6 caplets per day• children under 12 years: ask a doctor

Regulatory & Marketing

Labeler Name
O Positiv, Inc.
Product Type
Human Otc Drug
FDA Application #
M013
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-05-2022
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 83049-489-08 identifies a specific commercial package of 3 blister pack in 1 carton / 8 tablet in 1 blister pack of Flo Pms Complete, a human over the counter drug labeled by O Positiv, Inc.. This tablet is formulated for oral use and contains acetaminophen; caffeine; pyrilamine maleate 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 O Positiv, Inc. on December 05, 2022. The current certification is valid through December 31, 2026.

How is this O Positiv, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83049048908. 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 (5-3-2)
83049-489-08
11-Digit CMS (5-4-2)
83049-0489-08

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