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| Product NDC Code | 59556-895 | ||||||||||||||||||||||
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| 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 | CAPSULE, LIQUID FILLED | ||||||||||||||||||||||
| RxCUI drug identifier | 310964 | ||||||||||||||||||||||
| Application Number | ANDA204469 | ||||||||||||||||||||||
| Labeler Name | Strides Pharma 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.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 exceed 6 capsules 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.Inactive ingredients Ibuprofen Capsules FD&C blue 1, gelatin, gelatin (hydrolyzed), medium chain triglyceride, PEG 600, potassium hydroxide, purified water, sorbital and sorbitan solution. Printing ink: propylene glycol, shellac resins, sodium lauryl sulphate, titanium dioxide. Ibuprofen Capsules – Minis FD&C green no.3, gelatin, gelatin (hydrolyzed), lecithin (Soya Lecithin), medium chain triglyceride, polyethylene Glycol 600, potassium hydroxide, purified water, sorbital and sorbitan solution. Printing ink: propylene glycol, shellac resins, sodium lauryl sulphate, 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 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.Purpose Pain reliever/Fever reducer
Spl product data elements
Usually a list of ingredients in a drug product.IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POTASSIUM HYDROXIDE POLYETHYLENE GLYCOL 600 WATER GELATIN SORBITOL SORBITAN FD&C BLUE NO. 1 MEDIUM-CHAIN TRIGLYCERIDES PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TITANIUM DIOXIDE transparent green to bluish green oblong shaped IBUPROFEN IBUPROFEN IBUPROFEN IBUPROFEN POTASSIUM HYDROXIDE POLYETHYLENE GLYCOL 600 WATER GELATIN SORBITOL MEDIUM-CHAIN TRIGLYCERIDES PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE TITANIUM DIOXIDE FD&C GREEN NO. 3 LECITHIN, SOYBEAN SORBITAN transparent green to bluish green 469
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.PRINCIPAL DISPLAY PANELS Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) Liquid Filled Capsules Ibuprofen Capsules, 200 mg Pain Reliever/Fever Reducer (NSAID) Liquid Filled Capsules - Minis 160s count Ibuprofen carton label 80s count Ibuprofen minis carton label 80s count minis 160s count minis
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information each capsule contains: potassium 17.840 mg read all warnings and directions before use. Keep carton. store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)
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 toll free 1-877-244-9825 Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing. For most recent product information, visit us at www.strides.com Revised: 05/2023 Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
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 rash blisters 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 aged 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. 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 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 under a doctor's care for any serious condition taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin 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 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 If 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.
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