Extra Strenght Headache Relief Tablet
NDC Package 29485-6538-6
Package Information
Extra Strenght Headache Relief (acetaminophen, aspirin, caffeine) tablets is do not use more than directed (seeOVERDOSE WARNING) drink a full glass of water with each doseadults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hourschildren under 12 years: ask a doctor. This formulation utilizes a tablet delivery system. Marketed by Lil' Drug Store Products, Inc., this product is identified by NDC 29485-6538 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
- 29485 - Lil' Drug Store Products, Inc.
- 29485-6538 - Extra Strenght Headache Relief
- 29485-6538-6 - 3 POUCH in 1 CARTON / 2 TABLET in 1 POUCH
- 29485-6538 - Extra Strenght 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 29485-6538-6 identifies a specific commercial package of 3 pouch in 1 carton / 2 tablet in 1 pouch of Extra Strenght Headache Relief, a human over the counter drug labeled by Lil' Drug Store Products, Inc.. This tablet 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 Lil' Drug Store Products, Inc. on August 25, 2021.
How is this Lil' Drug Store Products, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 29485653806. 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 Package segment to maintain the 5-4-2 structure.