NDC 11673-305 Extra Strength Headache Relief

Acetaminophen-aspirin-caffeine

NDC Product Code 11673-305

NDC CODE: 11673-305

Proprietary Name: Extra Strength Headache Relief 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-aspirin-caffeine 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • 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.
  • Aspirin is used to reduce fever and relieve mild to moderate pain from conditions such as muscle aches, toothaches, common cold, and headaches. It may also be used to reduce pain and swelling in conditions such as arthritis. Aspirin is known as a salicylate and a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking a certain natural substance in your body to reduce pain and swelling. Consult your doctor before treating a child younger than 12 years. Your doctor may direct you to take a low dose of aspirin to prevent blood clots. This effect reduces the risk of stroke and heart attack. If you have recently had surgery on clogged arteries (such as bypass surgery, carotid endarterectomy, coronary stent), your doctor may direct you to use aspirin in low doses as a blood thinner to prevent blood clots.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: OVAL (C48345)
Size(s):
17 MM
Imprint(s):
TCL370
Score: 1

NDC Code Structure

  • 11673 - Target Corporation

NDC 11673-305-01

Package Description: 100 TABLET, COATED in 1 BOTTLE

NDC Product Information

Extra Strength Headache Relief with NDC 11673-305 is a a human over the counter drug product labeled by Target Corporation. The generic name of Extra Strength Headache Relief is acetaminophen-aspirin-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.

Extra Strength 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.

  • CAFFEINE 65 mg/1
  • ACETAMINOPHEN 250 mg/1
  • ASPIRIN 250 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.

  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • POVIDONE (UNII: FZ989GH94E)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: 01-01-2020 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.

Extra Strength Headache Relief Product Label Images

Extra Strength 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

ACETAMINOPHEN 250 MG - ASPIRIN 250 MG (nsaid*) CAFFEINE 65 MG - * NONSTEROIDAL ANIT-INFLAMMATORY DRUG

Inactive Ingredient

STEARIC ACID

MINERAL OIL

SILICON DIOXIDE

HYPROMELLOSES
MICROCRYSTALLINE CELLULOSE

STARCH, CORN

POVIDONE

CARNAUBA WAX
TITANIUM DIOXIDE

SODIUM STARCH GLYCOLATE

Otc - Purpose

PURPOSEPAIN RELIEVER - PAIN RELIEVER AID

Indications & Usage

TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

Dosage & Administration

DO NOT USE MORE THAN DIRECTED - DRINK A FULL GLASS OF WATER WITH EACH DOSE - ADULTS AND CHILDREN 12 YEARS AND OVER: TAKE 2 CAPLETS EVERY 6 HOURS, NOT MORE THAN 8 CAPLETS IN 24 HOURS.

CHILDREN UNDER 12 YEARS: ASK A DOCTOR

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDRENIn case of accidental overdose, get medical help or contact a Poison Control Center (1 800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Warnings

WARNINGSREYE'S SYNDROME:Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.ALLERGY ALERTAspirin may cause a severe allergic reaction which may include:hivesfacial swellingasthma (sneezing)shockLIVER WARNING:This product contains acetaminophen. Severe liver damage may occur if you takemore than 8 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 productSTOMACH BLEEDING WARNING:This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:are age 60 or older;have had stomach ulcers or bleeding problemstake a blood-thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)take more or for a longer time than directedCAFFEINE 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 which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heartbeat.

* Please review the disclaimer below.