Headache Relief Tablet, Film Coated
NDC Package 57243-159-08
Package Information
Headache Relief (acetaminophen, aspirin and caffeine) tablets is do not use more than directeddrink a full glass of water with each dose adults and children 12 years and over take 2 tablets every 6 hours do not take more than 8 tablets in 24 hourschildren under 12 years: ask a doctor. This formulation utilizes a tablet, film coated delivery system. Marketed by Salado Sales, Inc., this product is identified by NDC 57243-159 and is authorized under FDA application M013.
Identification & Billing
- RxCUI: 308297 - acetaminophen 250 MG / aspirin 250 MG / caffeine 65 MG Oral Tablet
- RxCUI: 308297 - APAP 250 MG / ASA 250 MG / caffeine 65 MG Oral Tablet
Clinical Specifications
- Anti-Inflammatory Agents, Non-Steroidal - [CS]
- Central Nervous System Stimulant - [EPC] (Established Pharmacologic Class)
- Central Nervous System Stimulation - [PE] (Physiologic Effect)
- Cyclooxygenase Inhibitors - [MoA] (Mechanism of Action)
- Decreased Platelet Aggregation - [PE] (Physiologic Effect)
- Decreased Prostaglandin Production - [PE] (Physiologic Effect)
- Methylxanthine - [EPC] (Established Pharmacologic Class)
- Nonsteroidal Anti-inflammatory Drug - [EPC] (Established Pharmacologic Class)
- Platelet Aggregation Inhibitor - [EPC] (Established Pharmacologic Class)
- Xanthines - [CS]
Regulatory & Marketing
Hierarchy Structure
- 57243 - Salado Sales, Inc.
- 57243-159 - Headache Relief
- 57243-159-08 - 1 BOTTLE, PLASTIC in 1 CARTON / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
- 57243-159 - Headache 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 57243-159-08 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 24 tablet, film coated in 1 bottle, plastic of Headache Relief Extra Strength, a human over the counter drug labeled by Salado Sales, Inc.. This tablet, film coated is formulated for oral use and contains acetaminophen; aspirin; caffeine 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 Salado Sales, Inc. on November 17, 1992. The current certification is valid through December 31, 2027.
How is this Salado Sales, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 57243015908. 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.