NDC 11673-683 Ibuprofen Mini

Ibuprofen Mini 200 Mg

NDC Product Code 11673-683

NDC CODE: 11673-683

Proprietary Name: Ibuprofen Mini 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: Ibuprofen Mini 200 Mg 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):
GREEN (C48329)
Shape: CAPSULE (C48336)
Size(s):
6 MM
Imprint(s):
62
Score: 1

NDC Code Structure

NDC 11673-683-32

Package Description: 300 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 11673-683-66

Package Description: 1 BOTTLE in 1 CARTON > 160 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC 11673-683-80

Package Description: 1 BOTTLE in 1 CARTON > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE

NDC Product Information

Ibuprofen Mini with NDC 11673-683 is a a human over the counter drug product labeled by Target Corporation. The generic name of Ibuprofen Mini is ibuprofen mini 200 mg. The product's dosage form is capsule, liquid filled and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 310964.

Dosage Form: Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.

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.

Ibuprofen Mini 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.


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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
  • GELATIN (UNII: 2G86QN327L)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • FERROUS OXIDE (UNII: G7036X8B5H)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • AMMONIA (UNII: 5138Q19F1X)
  • SORBITOL (UNII: 506T60A25R)
  • SHELLAC (UNII: 46N107B71O)

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: ANDA079205 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: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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: 12-17-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ibuprofen Mini 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 ingredient (in each capsule)Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*(present as the free acid and potassium salt)*nonsteroidal anti-inflammatory drug

Otc - Purpose

Purpose Pain reliever/Fever reducer

Indications & Usage

  • Uses temporarily relieves minor aches and pains due to:headachetoothachebackachemenstrual crampsthe common coldmuscular achesminor pain of arthritistemporarily reduces fever

Warnings

  • Warnings Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
  • Hivesfacial swellingasthma (wheezing)shockskin reddeningrashblistersIf an allergic reaction occurs, stop use and seek medical help right away.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • Are age 60 or olderhave 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]have 3 or more alcoholic drinks every day while using this producttake more or for a longer time than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.
  • These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Otc - Do Not Use

  • Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgery

Otc - Ask Doctor

  • Ask a doctor before use if stomach bleeding warning applies to youyou have problems or serious side effects from taking pain relievers or fever reducersyou have a history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diuretic

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you areunder a doctor's care for any serious conditiontaking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirintaking any other drug

Otc - When Using

  • When using this producttake with food or milk if stomach upset occurs

Otc - Stop Use

  • Stop use and ask a doctor if you experience any of the following signs of stomach bleeding:feel faintvomit bloodhave bloody or black stoolshave stomach pain that does not get betteryou have symptoms of heart problems or stroke:chest paintrouble breathingweakness in one part or side of bodyslurred speechleg swellingpain gets worse or lasts more than 10 daysfever gets worse or lasts more than 3 daysredness or swelling is present in the painful areaany new symptoms appear

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Dosage & Administration

  • Directionsdo not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not exceed 6 capsules in 24 hours, unless directed by a doctorchildren under 12 years: ask a doctor

Other Safety Information

  • Other information each capsule contains:
  • Potassium 20 mgread all warnings and directions before usestore at 20-25ºC (68-77ºF)avoid excessive heat above 40°C (104°F)

Inactive Ingredient

Inactive ingredients ammonium hydroxide, FD&C green no. 3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, shellac, sorbitan monooleate, sorbital sorbitan

Otc - Questions

Questions? call
1-800-910-6874

* Please review the disclaimer below.