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| Product NDC Code | 73598-1104 | ||||
|---|---|---|---|---|---|
| Drug Name | Ibuprofen 250 |
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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, COATED | ||||
| Application Number | ANDA072096 | ||||
| Labeler Name | JHK Inc dba American Safety & First Aid | ||||
| 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 ingredient (In Each Tablets) Ibuprofen, USP 200 mg (NSAID) *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 do not take longer than 10 days, unless directed by a doctor (see Warnings ) Adults: 1 tablet every 4 to 6 hours while symptoms occur; if pain or fever does not respond to 1 tablet, 2 tablets may be used, but do not exceed 6 tablets in 24 hours unless directed by a doctor. Children under 12 years: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients crosscarmellose sodium contains one or more of these ingredients , 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 ,
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.Use temporarily relieves fever and minor aches and pains associated with: common cold backache headache toothache arthritis muscular aches menstrual cramps
Purpose
Information about the drug product’s indications for use.Purpose pain reliever/fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.IBUPROFEN 100 IBUPROFEN IBUPROFEN IBUPROFEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE RED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN G2 IBUPROFEN 250 IBUPROFEN IBUPROFEN IBUPROFEN CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FD&C RED NO. 40 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED FERRIC OXIDE RED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MALTODEXTRIN MEDIUM-CHAIN TRIGLYCERIDES MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE K30 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A STARCH, CORN STEARIC ACID TALC TITANIUM DIOXIDE TRIACETIN G2
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 - 100 Tablet Packet Box This product is not manufactured or distributed by Pfizer Consumer Healthcare Owner of the registered trademark Advil ® . Product #1102 Ibuprofen Pain Reliever/Fever Reducer Active ingredient: Ibuprofen Temporary relief from pain, fever and inflammation Soothes muscles aches and minor arthritis pain Non-drowsy, aspirin-free formula These quality comfort tablets are formulated and packaged for use in the workplace and meet ANSI Z308.1-2015 standards. They are sealed in tamper-evident packets for safety and convenience. 100 Tablets • 2 Tablets Per Packet PRINCIPAL DISPLAY PANEL - 100 Tablet Packet Box
PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box Product #1104 Ibuprofen Pain Reliever/Fever Reducer Active ingredient: Ibuprofen Temporary relief from pain, fever and inflammation Soothes muscles aches and minor arthritis pain Non-drowsy, aspirin-free formula These quality comfort tablets are formulated and packaged for use in the workplace and meet ANSI Z308.1-2015 standards. They are sealed in tamper-evident packets for safety and convenience. 250 Tablets • 2 Tablets Per Packet PRINCIPAL DISPLAY PANEL - 250 Tablet Packet Box
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, or kidney disease you are taking a diuretic
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 taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) drug under a doctor's care for any serious condition 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 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 right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-866-651-3660 Monday-Friday 8:00am-5:00pm EST
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 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 long term continuous use may increase the risk of heart attack or stroke
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information do not use if packet is opened or torn Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
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 asthma (wheezing) facial swelling shock skin reddening rash 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 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 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, or kidney disease you are taking a diuretic Ask a doctor or pharmacist before use if you are taking any other drug containing an NSAID (prescription or nonprescription) taking a blood thinning (anticoagulant) drug under a doctor's care for any serious condition taking any other drug When using this product take with food or milk if stomach upset occurs long term continuous use may increase the risk of heart attack or stroke 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 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 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