NDC 11673-342 Acetaminophen

Acetaminophen

NDC Product Code 11673-342

NDC Code: 11673-342

Proprietary Name: Acetaminophen 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):
RED (C48326)
Shape: ROUND (C48348)
Size(s):
11 MM
Imprint(s):
TCL342
Score: 1

NDC Code Structure

  • 11673 - Target Corporation
    • 11673-342 - Acetaminophen

NDC 11673-342-01

Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

NDC 11673-342-26

Package Description: 225 TABLET, FILM COATED in 1 BOTTLE

NDC 11673-342-42

Package Description: 24 TABLET, FILM COATED in 1 BOTTLE

NDC Product Information

Acetaminophen with NDC 11673-342 is a a human over the counter drug product labeled by Target Corporation. The generic name of Acetaminophen is acetaminophen. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Target 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.

Acetaminophen 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.

  • POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • POVIDONE (UNII: FZ989GH94E)

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: Target Corporation
Labeler Code: 11673
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: 06-01-2019 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.

Acetaminophen 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

Active Ingredients

Active Ingredient: Each tablet contains Acetaminophen 500 mg

Inactive Ingredients

CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE** MAY CONTAIN THIS INGREDIENT

Otc - Purpose

PURPOSE: Pain Reliever - fever reducer

Otc - Keep Out Of Reach Of Children

Keep Out of the Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away

Indications & Usage

INDICATIONS AND USAGE:Pain Reliever – temporarily relieves minor aches and pains due to: the common cold, headache, backache, muscular aches, toothache, premenstrual and menstrual cramps, minor pain of arthritis. Temporarily reduces fever.

Warnings

Warnings;

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 amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen.
Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Dosage & Administration

Do not take more than directed (see overdosage warning)Adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctorChildren under 12 years: Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) of acetaminophen and may cause liver damage

* Please review the disclaimer below.

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