NDC 0924-0223 First Aid Only Extra-strength Non-aspirin

Acetaminophen

NDC Product Code 0924-0223

NDC Code: 0924-0223

Proprietary Name: First Aid Only Extra-strength Non-aspirin What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen 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.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
AZ;235
Score: 1

NDC Code Structure

  • 0924 - Acme United Corporation
    • 0924-0223 - First Aid Only Extra-strength Non-aspirin

NDC 0924-0223-01

Package Description: 20 PACKET in 1 BOX, UNIT-DOSE > 2 TABLET, FILM COATED in 1 PACKET

NDC Product Information

First Aid Only Extra-strength Non-aspirin with NDC 0924-0223 is a a human over the counter drug product labeled by Acme United Corporation. The generic name of First Aid Only Extra-strength Non-aspirin is acetaminophen. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Acme United Corporation

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

Product Type: Human Otc Drug 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.

First Aid Only Extra-strength Non-aspirin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ACETAMINOPHEN 500 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Acme United Corporation
Labeler Code: 0924
FDA Application Number: part343 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 12-30-2008 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

First Aid Only Extra-strength Non-aspirin Product Label Images

First Aid Only Extra-strength Non-aspirin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

  • Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
  • More than 8 tablets in 24 hours, which is the maximum daily amountwith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

Active Ingredient (In Each Tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

  • For the temporary relief of minor aches and pains associated withheadachetoothacheminor arthritis painmuscular achescommon coldmenstrual crampstemporarily reduces fever

Allergy Alert:

  • Acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

Do Not Use

  • With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug
  • Contains acetaminophen, ask a doctor or pharmacist.
  • For more than 10 days for pain unless directed by a doctorfor more than 3 days for fever unless directed by a doctor

Ask A Doctor Before Use If You Have

  • Liver disease

Ask A Doctor Or Pharmacist Before Use If

  • You are taking the blood thinning drug warfarin

Stop Using And Ask A Doctor If

  • Symptoms do not improvepain or fever persists or gets worsenew symptoms occurredness or swelling is present

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • Do not use more than directed

Adults And Children: (12 Years And Older)

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

Children Under 12 Years:

Do not give this adult strength product to children under 12 years of age;this will provide more than the recommended dose (overdose) and may cause liver damage.

Other Information

  • Store at room temperature 59º-86ºF (15º-30ºC)tamper-evident sealed packetsdo not use any opened or torn packets

Inactive Ingredients

Corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized corn starch*, sodium starch glycolate*, stearic acid, titanium dioxide**



May contain

Otc - Questions

Questions? 1-800-835-2263

First Aid Only Extra-Strength Non-Aspirin Label

First Aid Only Extra-Strength Non-Aspirin Label

* Please review the disclaimer below.