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| Product NDC Code | 62207-366 | ||||||||||||||||||||||||||||||||||
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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 | TABLET | ||||||||||||||||||||||||||||||||||
| RxCUI drug identifier | 310965 | ||||||||||||||||||||||||||||||||||
| Application Number | ANDA079174 | ||||||||||||||||||||||||||||||||||
| Labeler Name | Granules India Limited | ||||||||||||||||||||||||||||||||||
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT (in each tablet/caplet) Ibuprofen 200 mg (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.DIRECTIONS do not take more than directed the smallest effective dose should be used adults and children 12 years and older take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor
| adults and children 12 years and older |
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| children under 12 years |
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS colloidal silicon dioxide, iron oxide red, maize starch, poly ethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, 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 muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps 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 STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED IBUPROFEN IBUPROFEN TALC POLYETHYLENE GLYCOL 4000 Reddish Brown G;2 Ibuprofen Ibuprofen POLYETHYLENE GLYCOL 4000 STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED IBUPROFEN IBUPROFEN TALC Reddish Brown (Capsule shaped tablet) G;2 Ibuprofen Ibuprofen STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED IBUPROFEN IBUPROFEN POLYETHYLENE GLYCOL 4000 TALC Reddish Brown (Capsule shaped tablet) G;2 Ibuprofen Ibuprofen STARCH, CORN POVIDONE K30 STEARIC ACID SILICON DIOXIDE IBUPROFEN IBUPROFEN SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE FERRIC OXIDE RED TALC POLYETHYLENE GLYCOL 4000 Reddish Brown G;2
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.PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC# 62207-366-46 See New Warnings Information IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) Do not use if foil inner seal is broken or missing. 250 Coated Caplets † † Capsule-Shaped Tablets Important: Read all product information before using. Do not use if the foil inner seal is broken or missing NDC# 62207-366-47 Do not use if the foil inner seal is broken or missing See New Warnings Information IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) Do not use if foil inner seal is broken or missing. 500 Coated Caplets† †Capsule-Shaped Tablets Important: Read all product information before using. NDC# 62207-396-46 See New Warnings Information IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) Do not use if foil inner seal is broken or missing. 250 Coated Caplets† †Capsule-Shaped Tablets Important: Read all product information before using. NDC# 62207-396-46 Do not use if the foil inner seal is broken or missing See New Warnings Information IBUPROFEN TABLETS USP, 200 mg Pain Reliever/Fever Reducer (NSAID)* Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye) Do not use if foil inner seal is broken or missing. 500 Coated Caplets† †Capsule-Shaped Tablets Important: Read all product information before using. ibu-366-250ct-carton.jpg ibu-366-500ct-label.jpg ibu-396-250ct-carton.jpg ibu-396-250ct-label.jpg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information store at 20-25°C (68-77°F)[See USP Controlled Room Temperature] avoid high humidity and excessive heat above 40°C (104°F)
Manufactured By: Granules India Limited Hyderabad – 500 043, India MADE IN INDIA M.L.No: 37/RR/AP/2003/F/R Distributed By: Granules USA, Inc. Parsippany, NJ 07054
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.ASK A DOCTOR BEFORE USE IF you have problems or serious side effects from taking pain relievers or fever reducers the stomach bleeding warning applies to you 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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.DO NOT USE if you have ever had an allergic reaction to Ibuprofen or any other pain reliever/fever reducer right before or after heart surgery
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. (1-800-222-1222)
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 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT take with food or milk if stomach upset occurs
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 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.
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 age 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.
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