NDC 72090-002 Pain Reliever / Fever Reducer

Ibuprofen

NDC Product Code 72090-002

NDC CODE: 72090-002

Proprietary Name: Pain Reliever / Fever Reducer 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 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.

  • Ibuprofen is used to help relieve mild to moderate pain. When used with an opioid (such as morphine), it may be used to relieve moderate to severe pain. It is also used to reduce fever. Ibuprofen is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

Product Characteristics

Color(s):
BROWN (C48332)
Shape: ROUND (C48348)
Size(s):
10 MM
Imprint(s):
G;2
Score: 1

NDC Code Structure

  • 72090 - Pioneer Life Sciences, Llc

NDC 72090-002-01

Package Description: 500 TABLET in 1 BOTTLE

NDC Product Information

Pain Reliever / Fever Reducer with NDC 72090-002 is a a human over the counter drug product labeled by Pioneer Life Sciences, Llc. The generic name of Pain Reliever / Fever Reducer is ibuprofen. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Pioneer Life Sciences, Llc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Pain Reliever / Fever Reducer 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.

  • IBUPROFEN 200 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)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • POVIDONE K30 (UNII: U725QWY32X)
  • WATER (UNII: 059QF0KO0R)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Pioneer Life Sciences, Llc
Labeler Code: 72090
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: 05-18-2021 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.

Pain Reliever / Fever Reducer Product Label Images

Pain Reliever / Fever Reducer 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

Ibuprofen 200 mg (NSAID)11 - nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/Fever reducer

Uses:

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

Warnings:

  • Allergy alertIbuprofen 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 warningThis product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if youare 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 directedDo not useif you have ever had an allergic reaction to any other pain reliever/fever reducerright before or after heart surgeryAsk a doctor before use ifstomach 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 diureticAsk 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 drugWhen using this producttake with food or milk if stomach upset occursStop use and ask a doctor ifyou 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 appearIf 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.
  • Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Do not take more than directedthe smallest effective dose should be usedadults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be useddo not exceed 6 tablets in 24 hours, unless directed by a doctorchildren under 12 years: ask a doctor

Other Information

  • Each tablet contains: sodium 22mg
  • Read all product information before use.store at 20-25°C (68-77°F)avoid excessive heat above 40°C (104°F)

Inactive Ingredients

Pregelatinized Starch, Maize Starch, Sodium Starch Glycolate, Povidone K-30, Purified Water, Stearic Acid, Colloidal Silicon Dioxide, Opadry II 85F565026

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.

* Please review the disclaimer below.