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| Product NDC Code | 50332-0130 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Proprinal |
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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 | CAPSULE, LIQUID FILLED | ||||||||||||
| RxCUI drug identifier | 310964, 2673691 |
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| Application Number | ANDA079205 | ||||||||||||
| Labeler Name | HART Health | ||||||||||||
| 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 capsule) Solubilized Ibuprofen equal to 200 mg ibuprofen (NSAID)* (present as the free acid and potassium salt) * 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 capsule every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 capsule, 2 capsules may be used do not take more than 6 capsules in 24 hours, unless directed by a doctor children under 12 years of age : ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ammonium hydroxide, FD&C green #3, gelatin, iron oxide black, medium chain triglycerides, polyethylene glycol, propylene glycol, potassium hydroxide, purified water, shellac, sorbitan monooleate, sorbitol sorbitan
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: headache muscular aches backache minor arthritis pain the common cold toothache menstrual cramps Temporarily reduces fever
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.PROPRINAL Ibuprofen Capsules 200 mg WATER SHELLAC FD&C GREEN NO. 3 AMMONIA GELATIN FERROSOFERRIC OXIDE POLYETHYLENE GLYCOL, UNSPECIFIED IBUPROFEN IBUPROFEN MEDIUM-CHAIN TRIGLYCERIDES PROPYLENE GLYCOL POTASSIUM HYDROXIDE SORBITAN MONOOLEATE SORBITOL 133
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.Proprinal.jpg
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 problems or serious side effects from taking pain relievers or fever reducers 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
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 take aspirin for heart attack or stroke (ibuprofen may decrease this benefit of aspirin) take 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 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 (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION Other information each capsule contains: potassium 20 mg caplets enclosed in a sealed packet do not use if packet is torn, cut or open store at 59° to 86°F (15°-30°C) avoid excessive heat and humidity
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 an allergic reaction occurs, seek medical help right away fever worsens or lasts more than 3 days pain worsens or lasts more than 10 days you have any of the following signs of stomach bleeding: feel faint, vomit blood, have bloody or black stools, or stomach pain that does not get better new symptoms occur redness or swelling is present you have symptoms of heart problems or stroke: chest pain, trouble breathing, weakness in one part or side of the body, slurred speech, or leg swelling
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 produc 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 at 20 weeks or later in 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 blisters shock facial swelling asthma (wheezing) rash skin reddening 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. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
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