NDC 11673-240 Children Pain And Fever Reliver

Acetaminophen

NDC Product Code 11673-240

NDC CODE: 11673-240

Proprietary Name: Children Pain And Fever Reliver 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.

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.

Product Characteristics

Color(s):
PINK (C48328)
Shape: ROUND (C48348)
Size(s):
16 MM
Imprint(s):
RP160
Score: 2
Flavor(s):
BUBBLE GUM (C73368)

NDC Code Structure

  • 11673 - Target Corporation

NDC 11673-240-24

Package Description: 4 BLISTER PACK in 1 CARTON > 6 TABLET, CHEWABLE in 1 BLISTER PACK

NDC Product Information

Children Pain And Fever Reliver with NDC 11673-240 is a a human over the counter drug product labeled by Target Corporation. The generic name of Children Pain And Fever Reliver is acetaminophen. The product's dosage form is tablet, chewable and is administered via oral form.

Labeler Name: Target Corporation

Dosage Form: Tablet, Chewable - A solid dosage form containing medicinal substances with or without suitable diluents that is intended to be chewed, producing a pleasant tasting residue in the oral cavity that is easily swallowed and does not leave a bitter or unpleasant after-taste.

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.

Children Pain And Fever Reliver 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 160 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
  • D&C RED NO. 27 (UNII: 2LRS185U6K)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
  • GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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: 11-11-2019 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: 12-31-2021 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.

Information for Patients

Acetaminophen

Acetaminophen is pronounced as (a set a mee' noe fen)

Why is acetaminophen medication prescribed?
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to va...
[Read More]

* Please review the disclaimer below.

Children Pain And Fever Reliver Product Label Images

Children Pain And Fever Reliver 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 Ingredient (In Each Chewable Tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • ▪temporarily relieves minor aches and pains due to: ▪the common cold▪flu▪headache▪sore throat▪toothache▪temporarily reduces fever

Warnings

  • Liver warning:  This product contains acetaminophen. Severe liver damage may occur if your child takes:▪more than 5 doses in 24 hours, which is the maximum daily amount▪with other drugs containing acetaminophen.Allergy Alert:acetaminophen may cause severe skin reaction. Symptom may include:▪skin reddening▪blister▪rash. If a skin reaction occurs, stop use and seek medical help right away.

Sore Throat Warning:

If sore throat is severe, persists for more than 2 days is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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. ▪if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask A Doctor Before Use If Your Child Has

Liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

Taking the blood thinning drug warfarin.

When Using This Product

Do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

  • ▪pain gets worse or lasts more than 5 days ▪fever gets worse or lasts more than 3 days ▪new symptoms occur ▪redness or swelling is presentThese could be signs of a serious condition.

Keep Out Of Reach Of Children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

  • •this product does not contain directions or complete warnings for adult use. •do not give more than directed (see overdose warning) •find the right dose on chart below. If possible, use weight to dose; otherwise use age. •chew completely do not swallow whole •repeat dose every 4 hours while symptoms last •do not give more than 5 times in 24 hoursWeight (lbs)under 2424-3536-4748-5960-7172-95Age (yr)under 2 years2-3 years 4-5 years6-8 years9-10 years11 yearsDose (tablets)* ask a doctor1 tablet1 ½ tablets2 tablets2 ½ tablets3 tablets

Other Information

  • •store at room temperature. Avoid high humidity. Protect from light. •see end flap for expiration date and lot number

Inactive Ingredients

Citric acid, crospovidone, D&C Red No. 30, dextrose, flavor, hydroxypropylcellulose, magnesium stearate, maltodextrin, silicon dioxide, sodium carboxymethylcellulose, starch, sucralose.

* Please review the disclaimer below.