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| Product NDC Code | 70729-002 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Dye free ibuprofen |
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| Type | Brand | ||||||
| Pharm Class | Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET | ||||||
| RxCUI drug identifier | 310965 | ||||||
| Application Number | ANDA075139 | ||||||
| Labeler Name | Breeden Brothers, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active in gredient (in each white tablet) Ibuprofen USP, 200 mg (NSAID)*
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 Drug Facts (continued)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients corn starch, colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, triacetin
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses _ temporarily relieves minor aches and pains due to: _ backache _ muscular aches _ minor pain of arthritis _ headache _ menstrual cramps _ toothache _ the common cold _ temporarily reduces fever Drug Facts (continued)
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
Spl product data elements
Usually a list of ingredients in a drug product.Dye Free Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN HYPROMELLOSE, UNSPECIFIED TRIACETIN MAGNESIUM STEARATE STEARIC ACID STARCH, CORN MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED ANHYDROUS LACTOSE SILICON DIOXIDE 44;438
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL b+b better by giving PRINCIPAL DISPLAY PANEL b+b better by giving
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if _ stomach bleeding warning applies to you _ you have a history of stomach problems, such as heartburn _ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke _ you are taking a diuretic _ you have problems or serious side effects from taking pain relievers or fever reducers
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are _ under a doctor's care for any serious condition _ taking any other drug Drug Facts (continued) _ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use _ if you have ever had an allergic reaction to any other pain reliever/fever reducer _ right before or after heart surgery
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information _ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN _ store between 20°-25°C (68°-77°F) _ avoid excessive heat 40°C (104°F) _ use by expiration date on package
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-901-2420 Dist. by Breeden Brothers, LLC Nashville, TN 37219
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if _ you experience any of the following signs of stomach bleeding: _ feel faint _ vomit blood _ have bloody or black stools _ 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 _ any new symptoms appear _ redness or swelling is present in the painful area Drug Facts (continued)
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product _ take with food or milk if stomach upset occurs
Pregnancy or breast feeding
Pregnancy or Breast feedingIf 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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 _ blisters 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: _ 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 Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. Drug Facts (continued) 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 _ stomach bleeding warning applies to you _ you have a history of stomach problems, such as heartburn _ you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke _ you are taking a diuretic _ 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 any other drug Drug Facts (continued) _ taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 _ vomit blood _ have bloody or black stools _ 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 _ any new symptoms appear _ redness or swelling is present in the painful area Drug Facts (continued) 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API