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| Product NDC Code | 42961-203 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Xpect 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 | ANDA079174 | ||||||
| Labeler Name | Cintas Corporation | ||||||
| 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.Activate ingredients (in each tablet) Ibuprofen, USP (NSAID)* 200 mg *nonsteroidal anti-inflammatory drug
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 dose 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 Other information do not use if packet is torn, cut, or opened Store between 20 ° -25 ° C (68 ° -77 ° F) avoid excessive heat above 40 ° C (104 ° F)
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carnauba wax*, colloidal silicon dioxide, corn starch*, hypromellose, lactose anhydrous*, lactose monohydrate (derived from milk)*, magnesium stearate*, maize starch*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, povidone k-30*, pregelatinized starch*, purified water*, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin* *may contain ingredient
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: muscular aches, backache, toothache, menstrual cramps, headache, the common cold, minor pain of arthritis, temporarily reduces fever Warnings Allergy alert: Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing), rash, skin reddening, 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 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 aspirin for heart attack or stroke, becuase 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 becuse 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 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 dose 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 Other information do not use if packet is torn, cut, or opened Store between 20 ° -25 ° C (68 ° -77 ° F) avoid excessive heat above 40 ° C (104 ° F) Inactive ingredients carnauba wax*, colloidal silicon dioxide, corn starch*, hypromellose, lactose anhydrous*, lactose monohydrate (derived from milk)*, magnesium stearate*, maize starch*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, povidone k-30*, pregelatinized starch*, purified water*, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin* *may contain ingredient Questions? 1-877-973-2811 Monday-Friday 8:00am-5:00pm
Purpose
Information about the drug product’s indications for use.Purpose Pain reliever/fever reducer Uses temporarily relieves minor aches and pains due to: muscular aches, backache, toothache, menstrual cramps, headache, the common cold, minor pain of arthritis, temporarily reduces fever Warnings Allergy alert: Ibuprofen may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing), rash, skin reddening, 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 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 aspirin for heart attack or stroke, becuase 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 becuse 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 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 dose 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 Other information do not use if packet is torn, cut, or opened Store between 20 ° -25 ° C (68 ° -77 ° F) avoid excessive heat above 40 ° C (104 ° F) Inactive ingredients carnauba wax*, colloidal silicon dioxide, corn starch*, hypromellose, lactose anhydrous*, lactose monohydrate (derived from milk)*, magnesium stearate*, maize starch*, microcrystalline cellulose*, polydextrose*, polyethylene glycol*, povidone k-30*, pregelatinized starch*, purified water*, red iron oxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin* *may contain ingredient Questions? 1-877-973-2811 Monday-Friday 8:00am-5:00pm
Spl product data elements
Usually a list of ingredients in a drug product.Xpect Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CARNAUBA WAX SILICON DIOXIDE STARCH, CORN HYPROMELLOSE, UNSPECIFIED ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 WATER FERRIC OXIDE RED SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID TITANIUM DIOXIDE TRIACETIN
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 - Wrapper FULL STRENGTH IBUPROFEN wrapper-01
Principal Display Panel - 100 count Box FULL STRENGTH IBUPROFEN Pain Reliever/Fever Reducer Compare active ingredient to Advil® Temporary relief from pain, fever, and arthritis inflammation Aspirin-free formula Xpect® First aid Active Ingredients: Ibuprofen (NSAID) WORKPLACE READY™ Single Dose Tamper Evident Non-Drowsy 100 Tablets • 2 Tablets per Packet box-100
Principal Display Panel - 250 count Box FULL STRENGTH IBUPROFEN Pain Reliever/Fever Reducer Compare active ingredient to Advil® Temporary relief from pain, fever, and arthritis inflammation Aspirin-free formula Xpect® First aid Active Ingredients: Ibuprofen (NSAID) WORKPLACE READY™ Single Dose Tamper Evident Non-Drowsy 250 Tablets • 2 Tablets per Packet box-250
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 aspirin for heart attack or stroke, becuase ibuprofen may decrease this benefit of aspirin taking any other drug
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 do not use if packet is torn, cut, or opened Store between 20 ° -25 ° C (68 ° -77 ° F) avoid excessive heat above 40 ° C (104 ° F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-973-2811 Monday-Friday 8:00am-5:00pm
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, 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
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 becuse 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 severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock, facial swelling, asthma (wheezing), rash, skin reddening, 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 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 aspirin for heart attack or stroke, becuase 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 becuse 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