Advil Allergy And Congestion Relief Tablet, Coated
NDC Package 0573-2161-03
Package Information
Advil Allergy And Congestion Relief (chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride) tablets is do not take more than directedadults and children 12 years of age and over:take 1 tablet every 4 hours while symptoms persistdo not take more than 6 tablets in any 24-hour period, unless directed by a doctorchildren under 12 years of age: do not use because this product contains too much medication for children under this age. This formulation utilizes a tablet, coated delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0573-2161 and is authorized under FDA application NDA022113.
Identification & Billing
- RxCUI: 1310503 - chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral Tablet
- RxCUI: 1310503 - chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 0573 - Haleon Us Holdings Llc
- 0573-2161 - Advil Allergy And Congestion Relief
- 0573-2161-03 - 2 BLISTER PACK in 1 CARTON / 10 TABLET, COATED in 1 BLISTER PACK
- 0573-2161 - Advil Allergy And Congestion Relief
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 0573-2161-03 identifies a specific commercial package of 2 blister pack in 1 carton / 10 tablet, coated in 1 blister pack of Advil Allergy And Congestion Relief, a human over the counter drug labeled by Haleon Us Holdings Llc. This tablet, coated is formulated for oral use and contains chlorpheniramine maleate; ibuprofen; 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 Haleon Us Holdings Llc on July 23, 2012. The current certification is valid through December 31, 2026.
How is this Haleon Us Holdings Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00573216103. 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.