Ibuprofen
Great Lakes Wholesale, Marketing, & Sales, Inc.
Human Otc Drug
NDC 64092-200Ibuprofen is a human otc drug labeled by 'Great Lakes Wholesale, Marketing, & Sales, Inc.'. National Drug Code (NDC) number for Ibuprofen is 64092-200. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Ibuprofen drug includes Ibuprofen - 200 mg/1 . The currest status of Ibuprofen drug is Active.
Drug Information:
| Drug NDC: | 64092-200 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Ibuprofen |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Ibuprofen |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Great Lakes Wholesale, Marketing, & Sales, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | IBUPROFEN - 200 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 24 May, 1988 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| 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. |
| Application Number: | ANDA075010 |
| 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. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 310965
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0792215802028
|
| UPC stands for Universal Product Code. |
| NUI: | N0000000160
M0001335
N0000175722
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | WK2XYI10QM
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class MOA: | Cyclooxygenase Inhibitors [MoA]
|
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. |
| Pharmacologic Class EPC: | Nonsteroidal Anti-inflammatory Drug [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class CS: | Anti-Inflammatory Agents, Non-Steroidal [CS]
|
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. |
| Pharmacologic Class: | Anti-Inflammatory Agents
Non-Steroidal [CS]
Cyclooxygenase Inhibitors [MoA]
Nonsteroidal Anti-inflammatory Drug [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 64092-200-30 | 1 BOTTLE, PLASTIC in 1 CARTON (64092-200-30) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 24 May, 1988 | N/A | No |
| 64092-200-50 | 1 BOTTLE, PLASTIC in 1 CARTON (64092-200-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 24 May, 1988 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose pain reliever/fever reducer
Product Elements:
Ibuprofen ibuprofen ibuprofen ibuprofen carnauba wax silicon dioxide starch, corn hypromellose, unspecified anhydrous lactose magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol, unspecified ferric oxide red sodium starch glycolate type a potato stearic acid titanium dioxide 44;291
Indications and Usage:
Uses temporarily relieves minor aches and pains due to: menstrual cramps toothache the common cold backache headache muscular aches minor pain of arthritis temporarily reduces fever
Warnings:
Warnings allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: skin reddening asthma (wheezing) rash facial swelling shock blisters hives if 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 take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug are age 60 or older take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen, or others] have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product 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 ha
Read more...d an allergic reaction to any other pain reliever/fever reducer right before or after heart surgery ask a doctor before use if you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers 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 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 you have symptoms of heart problems or stroke: chest pain slurred speech leg swelling trouble breathing weakness in one part or side of body 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.
Do Not Use:
Warnings allergy alert: ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: skin reddening asthma (wheezing) rash facial swelling shock blisters hives if 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 take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug are age 60 or older take other drugs containing prescription or nonprescription nsaids [aspirin, ibuprofen, naproxen, or others] have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product 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 surgery ask a doctor before use if you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers 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 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 you have symptoms of heart problems or stroke: chest pain slurred speech leg swelling trouble breathing weakness in one part or side of body 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.
When Using:
When using this product take with food or milk if stomach upset occurs
Dosage and Administration:
Directions do not take more than directed the smallest effective dose should be used adults and children 12 years and over: 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: ask a doctor
Stop Use:
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 you have symptoms of heart problems or stroke: chest pain slurred speech leg swelling trouble breathing weakness in one part or side of body 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
Package Label Principal Display Panel:
Principal display panel health care ndc 64092-200-50 compare to active ingredient in advil® tablets ibuprofen ibuprofen tablets usp, 200 mg pain reliever and fever reducer (nsaid) 50 tablets healthcare guarantee if you are not completely satisfied with this product, regardless of reason, return your unused portion to great lakes wholesale for a full refund tamper evident: do not use if imprinted safety seal under cap is broken or missing this product is not manufactured or distributed by wyeth llc, owner of the registered trademark advil® tablets. 50844 rev0618f29115 distributed by: great lakes wholesale & marketing l.l.c. 3729 patterson ave., s.e., grand rapids, mi 49512 www.glwholesale.com healthcare 44-291 healthcare 44-291
Further Questions:
Questions or comments? call 1-800-426-9391 8:30 am-4:00 pm et, monday-friday