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| Product NDC Code | 51824-064 | ||||
|---|---|---|---|---|---|
| Drug Name | Careall 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 | New World Imports | ||||
| 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.Ibuprofen 200mg (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.Do not take more than directed. The smallest effective dose should be used. Adult and children 12 years and older: Take 1 tablets every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablets, 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.colloidal silicon dioxide, corn starch, FD and C yellow 6, hypromellose, polydextrose, polyethylene glycol, povidone, pregelatinized starch, purified water, sodium starch glycolate, stearic acid, titanium dioxide
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.Temporarily relieves minor aches and pains due to: Headache, toothache, backache, menstrual cramps, the common cold, muscular aches, minor pain of arthritis. Temporarily reduces fever
Purpose
Information about the drug product’s indications for use.Pain reliever / fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.CAREALL Ibuprofen Ibuprofen Starch, Corn HYPROMELLOSES IBUPROFEN IBUPROFEN SILICON DIOXIDE FD&C YELLOW NO. 6 POVIDONE WATER STEARIC ACID TITANIUM DIOXIDE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM STARCH GLYCOLATE TYPE A POTATO Rusty brown color Round 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.IBUT100 Label
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.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.Store between 20-25 degrees celsius (68-77 degrees farhenheit). Read all warnings and directions before use Do not use if seal under bottle cap is broken or missing
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: Call 1-888-952-0050 Monday through Friday 9 AM - 5 PM EST
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.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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you a re 60 years or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoaglant) or steroid drug, take other drugs containing a NSAID [aspirin, ibuprofen, naproxen, or others], have 3 or more alcoholic drinks every day while using this product, or take more / for a longer time than directed. Heart attack and stroke warning: NSAID's, 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 or right before or after heart surgery. 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 a doctor or pharmacist before use if you are: taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin. 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. 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, trouble breathing, weakness in one part or side of body, slurred speech, or leg swelling. 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. 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.
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