8hr Muscle Aches And Pain Tablet, Extended Release
NDC 81522-201

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 81522-201?
  5. 8hr Muscle Aches And Pain Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Patient Education

Product Information

8hr Muscle Aches And Pain (acetaminophen) is a ANDA-approved product labeled by Fsa Store Inc.. 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. It is supplied as a white tablet, extended release for oral administration. This product entry covers the primary NDC 81522-201 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
81522-201
Proprietary Name:
8hr Muscle Aches And Pain
Non-Proprietary Name: [1]
Acetaminophen
Substance Name: [2]
Acetaminophen
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Tablet, Extended Release - A solid dosage form containing a drug which allows at least a reduction in dosing frequency as compared to that drug presented in conventional dosage form.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Fsa Store Inc.
Labeler Code:
81522
Product Label ID:
13268603-0080-22cf-e063-6394a90a7db4
FDA Application Number: [6]
ANDA211544
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
03-20-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
G650
Score:
1

Code Structure Chart

Product Details

What is NDC 81522-201?

The NDC code 81522-201 is assigned by the FDA to the product 8hr Muscle Aches And Pain. It is commonly known by its generic name, acetaminophen. This pharmaceutical product is labeled by Fsa Store Inc. and is currently categorized as listed product. The medication is a tablet, extended release administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 81522-201-03. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 650 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the full disclaimer at the bottom of this page.

Patient Education

Acetaminophen


Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
[Learn More]


Pain Relievers


What are pain relievers?

Pain relievers are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each with advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.

What are the types of over-the-counter pain relievers?

Over-the-counter (OTC) medicines are good for many types of pain. Two types of OTC pain medicines are usually recommended for mild to moderate pain.

  • Acetaminophen (Tylenol) is used in many OTC and prescription medicines. It's often considered safer than other pain relievers. Unfortunately, it's common for people to take too much accidentally. Be careful not to take too much each day or use more than one medicine with acetaminophen. Check with your health care provider before taking medicines containing acetaminophen for more than ten days or five days for your child.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) include aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin). These pain relievers are often most effective if you have pain and inflammation (swelling), such as for arthritis or menstrual cramps. If you take more than the recommended amount, NSAIDs may cause nausea, stomach pain, or ulcers.

What are prescription pain relievers?

If OTC pain relievers don't relieve your pain, your provider may prescribe something stronger. Many NSAIDs are also available at higher prescription doses.

The most powerful pain relievers are opioids, sometimes called narcotics. They include strong prescription pain relievers such as oxycodone, hydrocodone, or morphine. Opioids are sometimes used to treat moderate to severe pain. Your provider may give you a prescription to reduce pain after you have had a major injury or surgery.

Opioids are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under your provider's supervision.

What are some non-drug treatments for pain?

Pain relievers are just one part of a pain treatment plan. Environmental factors, stress, and beliefs about pain may affect the way you feel about pain and respond to treatment.

There are many things you can do to help ease pain. Treatment depends on the cause and type of pain. It's important to check with your provider before trying any of them. A few non-drug treatments for pain include:

  • Acupuncture
  • Hot or cold packs
  • Massage therapy
  • Physical therapy
  • Relaxation techniques

[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".