NDC 67060-002 Ibuprofen

Ibuprofen 200mg

NDC Product Code 67060-002

NDC 67060-002-67

Package Description: 250 PACKET in 1 CARTON > 2 TABLET, FILM COATED in 1 PACKET

NDC 67060-002-68

Package Description: 100 PACKET in 1 CARTON > 2 TABLET, FILM COATED in 1 PACKET

NDC Product Information

Ibuprofen with NDC 67060-002 is a a human over the counter drug product labeled by Advanced First Aid, Inc.. The generic name of Ibuprofen is ibuprofen 200mg. The product's dosage form is tablet, film coated and is administered via oral form.

Labeler Name: Advanced First Aid, Inc.

Dosage Form: Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.

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 1/1

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.

  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYVINYL ALCOHOL (UNII: 532B59J990)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: Advanced First Aid, Inc.
Labeler Code: 67060
FDA Application Number: ANDA091239 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: 03-20-2019 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: 12-31-2020 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.

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

Otc - Active Ingredient

ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)*nonsteroidal anti-inflammatory drug

Otc - Purpose

Pain reliever/fever reducer

Indications & Usage

Uses:temporarily relieves minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • toothache • menstrual cramps • common cold • temporarily reduces fever

Warnings

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 • blisters If an allergic reaction occurs, stop use and seek medical help right away.Stomach Bleeding Warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 non prescription 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.Heart 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.Do not use: • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgeryAsk a doctor before use if: • 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 heart burn • high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke • you are taking a diureticAsk a doctor or pharmacist before use if you are: • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin • under a doctor’s care for any serious condition • taking any other drugWhen using this product: • take with food or milk if stomach upset occursStop use and ask a doctor if: • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • or if redness or swelling is present in the painful area • any new symptoms appear • You experience any of the following signs of stomach bleeding: • feel faint • vomit blood • or have bloody or black stools • have stomach pain that does not get better • You have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of the body • slurred speach •leg swelling

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 specifically 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

Directions:Adults and children 12 years of age and older:• do not take more than directed • the smallest effective dose should be used • take 1 tablet every 4 to 6 hours while symptoms persist. • If pain or fever does not respond to 1 tablet, 2 tablets may be used • do not exceed 6 tablets in 24 hours, unless directed by a doctor.Children under 12 years of age: ask a doctor

Inactive Ingredient

Inactive Ingredients: croscarmellose sodium*, FD& C Blue #2*, FD& C Red #40*, FD& C Yellow #6*, hypromellose*, iron oxide red*, lactose monohydrate*, magnesium stearate*, maltodextrin*, medium chain triglycerides*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, polyvinyl alcohol*, Povidone (K-30)*, silicon dioxide, sodium starch glycolate*, starch, stearic acid*, talc*, titanium dioxide, triacetin*.*contains one or mored of these ingredients

* Please review the disclaimer below.

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