NDC 11673-839 Tension Headache Relief

Acetaminophen-caffeine

NDC Product Code 11673-839

NDC 11673-839-01

Package Description: 100 TABLET, COATED in 1 CARTON

NDC Product Information

Tension Headache Relief with NDC 11673-839 is a a human over the counter drug product labeled by Target Corporation. The generic name of Tension Headache Relief is acetaminophen-caffeine. The product's dosage form is tablet, coated and is administered via oral form.

Labeler Name: Target Corporation

Dosage Form: Tablet, Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is covered with a designated coating.

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.

Tension Headache Relief 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
  • CAFFEINE 65 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.

  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
  • FOOD YELLOW 3 FREE ACID (UNII: G2B7JWK1GG)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • TALC (UNII: 7SEV7J4R1U)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

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.
  • 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: 02-04-2020 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.

Tension Headache Relief Product Label Images

Tension Headache Relief 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

Otc - Active Ingredient

ACTIVE INGREDIENTS (IN EACH CAPLET)

Acetaminophen 500 mg - Caffeine 65 mg

Inactive Ingredient

Colloidal silicon dioxide, pregelatinized starch, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol (PEG 400), povidone stearic acid,talc, titanium dioxide

Otc - Purpose

Pain reliever - Pain reliever aid

Indications & Usage

USES

• temporarily relieves minor aches and pain due to: • headache - • muscular aches

Dosage & Administration

DIRECTIONS•

do not use more than directed



adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours



children under 12 years: ask a doctor

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 (1-800-222-1221). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings

WARNINGSAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:•

skin reddening



blisters



rash
If a skin reaction occurs, stop use and seek medical help right away.Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take•

more than 6 caplets in 24 hours, which is the maximum daily amount



with other drugs containing acetaminophen



3 or more alcoholic drinks every day while using this product
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

* Please review the disclaimer below.