NDC 70000-0172 Ibuprofen

Ibuprofen

NDC Product Code 70000-0172

NDC CODE: 70000-0172

Proprietary Name: Ibuprofen 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 for the short-term treatment of mild to moderate pain in adults. When used with a narcotic (such as morphine) it may be used to treat moderate to severe pain. It is also used to reduce fever. This medication is a nonsteroidal anti-inflammatory drug (NSAID).

Product Characteristics

Color(s):
BLUE (C48333)
Shape: CAPSULE (C48336)
Size(s):
19 MM
Imprint(s):
IB200
Score: 1

NDC Code Structure

  • 70000 - Cardinal Health (leader) 70000

NDC 70000-0172-1

Package Description: 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

NDC Product Information

Ibuprofen with NDC 70000-0172 is a a human over the counter drug product labeled by Cardinal Health (leader) 70000. The generic name of Ibuprofen is ibuprofen. The product's dosage form is capsule, liquid filled and is administered via oral form.

Labeler Name: Cardinal Health (leader) 70000

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 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.

  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • GELATIN (UNII: 2G86QN327L)
  • POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
  • POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN (UNII: 6O92ICV9RU)

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: Cardinal Health (leader) 70000
Labeler Code: 70000
FDA Application Number: ANDA078682 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: 11-30-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2021 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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

Ibuprofen

Ibuprofen is pronounced as (eye byoo' proe fen)

Why is ibuprofen medication prescribed?
Prescription ibuprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints)...
[Read More]

* Please review the disclaimer below.

Ibuprofen 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 Capsule)

Solubilized ibuprofen equal to 200 mg ibuprofen (NSAID)*(present as the free acid and potassium salt)*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily relieves minor aches and pains due to:
  • Headache
  • Muscular aches
  • Minor pain of arthritis
  • Toothache
  • Backache
  • The common cold
  • Menstrual cramps temporarily reduces fever

Warnings

  • Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hives
  • Facial swelling
  • Asthma (wheezing)
  • Shock
  • Skin reddening
  • Rash
  • BlistersIf 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 older
  • Have had stomach ulcers or bleeding problems
  • Take a blood thinning (anticoagulant) or steroid drug
  • Take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • Have 3 or more alcoholic drinks every day while using this product
  • Take more or for a longer time than directed

Do Not Use

  • If you have ever had an allergic reaction to any other pain reliever/fever reducer
  • Right before or after heart surgery

Ask A Doctor Before Use If

  • The stomach bleeding warning applies to you
  • You have problems or serious side effects from taking pain relievers or fever reducers
  • You have a history of stomach problems, such as heartburn
  • You have high blood pressure, heart disease, liver cirrhosis, kidney disease or asthma
  • You are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • Under a doctor's care for any serious condition
  • Taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
  • Taking any other drug

When Using This Product

  • Take with food or milk if stomach upset occurs
  • The risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor If

  • You experience any of the following signs of stomach bleeding:
  • Feel faint
  • Have bloody or black stools
  • Vomit blood
  • Have stomach pain that does not get better pain gets worse or lasts more than 10 days
  • Fever gets worse or lasts more than 3 days
  • Redness or swelling is present in the painful area
  • Any new symptoms appear

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.

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Do not take more than directedthe smallest effective dose should be usedadults 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 doctor children under 12 years: ask a doctor

Other Information

  • Each capsule contains: potassium 20 mg read all warnings and directions before use.
  • Store at 20° to 25°C (68° to 77°F)
  • Avoid excessive heat above 40°C (104°F). Protect from light.

Inactive Ingredients

FD&C blue #1, gelatin, pharmaceutical ink, polyethylene glycol, potassium hydroxide, purified water, sorbitan, sorbitol

Product Label

Leader Ibuprofen Softgels 200mg

* Please review the disclaimer below.