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| Product NDC Code | 69103-2525 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Flex-prin |
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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 | ANDA079129 | ||||||
| Labeler Name | Provision Medical Products | ||||||
| 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-IBUPROFEN 200 MG
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. Adults and children 12 years and older • Take 1 tablet every 4 to 6 hours while symptoms • If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless as directed by a doctor. • The smallest effective dose should be used. Children under 12 year • Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: carnauba wax, croscarmellose sodium, hydroxypropyl methylcellulose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid and 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.Uses: temporarily relieves minor aches and pains due to:•headache • minor pain of arthritis • the common cold • toothache • backache • menstrual cramps • muscular aches • 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.Flex-Prin Ibuprofen CROSCARMELLOSE SODIUM CARNAUBA WAX HYPROMELLOSES POLYETHYLENE GLYCOL 400 STEARIC ACID CELLULOSE, MICROCRYSTALLINE POVIDONE K30 STARCH, PREGELATINIZED CORN POLYSORBATE 80 SILICON DIOXIDE TITANIUM DIOXIDE TALC IBUPROFEN IBUPROFEN IBU200
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.FLEX PRIN BOX
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.
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 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 which may include: • hives • shock • facial swelling • asthma (wheezing) Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Ibuprofen or other pain relievers/ fever reducers. Ibuprofen may cause stomach bleeding. Do not use: • if you have ever had an allergic reaction to any other pain reliever/fever reducer Ask a doctor before use if you have: • stomach pain • problems or serious side eects 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 • taking any other product that contains Ibuprofen, or any other pain reliever/fever reducer When using this product give with food or milk if stomach upset occurs. Stop use and ask a doctor if: • an allergic reaction occurs. Seek medical help right away • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • stomach pain or upset gets worse or lasts • any new symptoms appear • redness or swelling is present in the painful area
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