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| Product NDC Code | 49483-612 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Ibuprofen |
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| Type | Generic | ||||||||
| 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, FILM COATED | ||||||||
| RxCUI drug identifier | 310965 | ||||||||
| Application Number | ANDA091237 | ||||||||
| Labeler Name | TIME CAP LABORATORIES,INC | ||||||||
| 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 200 mg (NSAID)* * nonstreoidal 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 do not take longer than 10 days, unless directed by a docter (see Wanings) adults and children 12 years and olderChildren under 12 years take 1 tablet every 4 to 6 hours while symptoms persistif pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor. ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.colloidal silicon dioxide, croscamellose sodiium, FD&C yellow #6, magnesium stearate,microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium
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 pain due to: backache,headache,menstrual cramps, minor pain of arthritis, muscular aches, the common cold, toothache, 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.IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 MAGNESIUM STEARATE POLYETHYLENE GLYCOL 3350 POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE 120 IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C YELLOW NO. 6 MAGNESIUM STEARATE POLYETHYLENE GLYCOL 3350 POLYVINYL ALCOHOL, UNSPECIFIED SILICON DIOXIDE STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE 115
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.IBUPROFEN TABLETS, USP ORANGE CAPSULE-SHAPED LABEL image description
IBUPROFEN TABLETS USP 200 MG ROUND ORANGE image description
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 PoisonControlCenter right away. (1-800-222-1222) Close
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 alerts: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin. Symptoms may include: asthma (wheezing),blisters,facial swelling,hives,rash,shock,skin reddening 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 stomach bleeding. The chance is higher if you:are age 60 or older; have bad stomach ulcers or bleeding problems;take a blood thinning (anticoagulant) or steroid drug; take other drug containing prescription NSAID (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
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