Tylenol Sinus Severe Tablet, Coated
NDC Package 70264-026-02
Package Information
Tylenol Sinus Severe (acetaminophen) tablets is a medication used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever. This formulation utilizes a tablet, coated delivery system. Marketed by R J General Corporation, this product is identified by NDC 70264-026 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1243679 - acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet
- RxCUI: 1243679 - acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
- RxCUI: 1243679 - APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet
- RxCUI: 1243679 - APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet
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)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 70264 - R J General Corporation
- 70264-026 - Tylenol Sinus Severe
- 70264-026-02 - 50 POUCH in 1 BOX / 2 TABLET, COATED in 1 POUCH
- 70264-026 - Tylenol Sinus Severe
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 70264-026-02 identifies a specific commercial package of 50 pouch in 1 box / 2 tablet, coated in 1 pouch of Tylenol Sinus Severe, a human over the counter drug labeled by R J General Corporation. This tablet, coated is formulated for oral use and contains acetaminophen; 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 R J General Corporation on May 01, 2021. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.
How is this R J General Corporation product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 70264002602. 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 Product segment to maintain the 5-4-2 structure.