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| Product NDC Code | 62207-762 | ||||||||||||||||||||||||||||
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| Drug Name | Naproxen sodium |
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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 | 849574 | ||||||||||||||||||||||||||||
| Application Number | ANDA091353 | ||||||||||||||||||||||||||||
| Labeler Name | Granules India Ltd | ||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT(S) (in each tablet/caplet) Naproxen sodium 220 mg (Naproxen 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 • drink a full glass of water with each dose Adults and children 12 years and older take 1 tablet every 8 to 12 hours while symptoms last for the first dose you may take 2 tablets within the first hour do not exceed 2 tablets in any 8- to 12-hour period do not exceed 3 tablets in a 24-hour period 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 INGREDIENT Inactive Ingredients FD&C blue#2 aluminum lake, hypromellose 2910, maize starch, microcrystalline cellulose, polyethylene glycol, povidone k-30, sodium starch glycolate, stearic acid, titanium dioxide Questions or Comments? 1-877-770-3183 Mon - Fri 9:00 AM to 4:30 PM EST Do not use if carton is open or of foil seal on bottle opening is missing or broken. Manufactured By: Granules India Limited Hyderabad –500 081, India MADE IN INDIA M.L. 37/RR/AP/2003/F/R
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.USE(S) • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • menstrual cramps • headache • toothache • the common cold • 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.Naproxen Sodium Naproxen Sodium FD&C BLUE NO. 2 HYPROMELLOSES STARCH, CORN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN Light Blue 220 Naproxen Sodium Naproxen Sodium FD&C BLUE NO. 2 HYPROMELLOSES STARCH, CORN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN Light Blue Caplet -Shaped 220 Naproxen Sodium Naproxen Sodium FD&C BLUE NO. 2 HYPROMELLOSES STARCH, CORN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN Light Blue 220 Naproxen Sodium Naproxen Sodium FD&C BLUE NO. 2 HYPROMELLOSES STARCH, CORN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN Light Blue Caplet -Shaped 220 Naproxen Sodium Naproxen Sodium FD&C BLUE NO. 2 HYPROMELLOSES STARCH, CORN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN Light Blue 220 Naproxen Sodium Naproxen Sodium FD&C BLUE NO. 2 HYPROMELLOSES STARCH, CORN CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL 400 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE NAPROXEN SODIUM NAPROXEN Light Blue Caplet -Shaped 220
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 PANEL naproxen-327-49-jpg naproxen-327-51-jpg naproxen-328-49-jpg naproxen-328-51-jpg naproxen-762-49-jpg.jpg naproxen-761-49-jpg.jpg naproxen-729-49-jpg.jpg naproxen-728-49-jpg.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.OTHER INFORMATION • each tablet contains: sodium 20 mg • store at 20 - 25°C (68 - 77°F). Avoid high humidity and excessive heat above 40°C (104°F)
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 • the stomach bleeding warning applies to you • you have a history of stomach problems, such as heartburn • you have had high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke • you are taking a diuretic • you have problems or serious side effects from taking pain relievers or fever reducers
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 • 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 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.
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 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 • you have difficulty swallowing • it feels like the pill is stuck in your throat • 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 feedingPREGNANCY/BREASTFEEDING If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of 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: Naproxen sodium 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