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| Product NDC Code | 67060-001 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | 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, FILM COATED | ||||||
| RxCUI drug identifier | 310965 | ||||||
| Application Number | ANDA079174 | ||||||
| Labeler Name | ADVANCED FIRST AID, INC. | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT IN EACH TABLET- Ibuprofen 200 mg (NSAID)
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: Adults and children 12 years of age and older: • do not take more than directed • the smallest effective dose should be used • take 1 tablet every 4 to 6 hours while symptoms persist. • If 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. Children under 12 years of age: do not use for children under 12 years of age unless directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: crosscarmellose sodium*, 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* *contains one or more of these ingredients
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 pain of arthritis • toothache • menstrual cramps • common cold • 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 200MG IBUPROFEN IBUPROFEN SILICON DIOXIDE POVIDONE K30 FERRIC OXIDE RED SODIUM STARCH GLYCOLATE TYPE A CORN STEARIC ACID POLYETHYLENE GLYCOL 400 HYPROMELLOSE 2208 (4000 MPA.S) STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE LACTOSE MONOHYDRATE 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.ADVANCED IBUPROFEN
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 specifically 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 • facial swelling • asthma (wheezing) • shock • skin reddening • 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 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 an 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. 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. Do not use: • if you have ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor use if you have: • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain • ulcers • bleeding problems • high blood pressure • heart disease, liver cirrhosis, or kidney disease • taken a diuretic • reached age 60 or older 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) or steroid drug • under a doctor’s care for any serious condition • taking any other drug taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding. • 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 • redness or swelling is present in the painful area • any new symptoms appear
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