NDC 0113-1412 Good Sense Naproxen Sodium
Naproxen Sodium Tablet, Film Coated Oral
Product Information
What is NDC 0113-1412?
The NDC code 0113-1412 is assigned by the FDA to the product Good Sense Naproxen Sodium which is a human over the counter drug product labeled by L. Perrigo Company. The generic name of Good Sense Naproxen Sodium is naproxen sodium. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0113-1412-71 1 bottle in 1 carton / 50 tablet, film coated in 1 bottle. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Good Sense Naproxen Sodium?
Naproxen is used to relieve pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis, bursitis, and gout attacks. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section. Some brands of sustained-release naproxen take longer to be absorbed and are not recommended for pain that needs quick relief (such as during a gout attack). Ask your doctor or pharmacist if you have questions about your particular brand.
Product Characteristics
Color(s) | BLUE (C48333) |
Shape | ROUND (C48348) |
Size(s) | 10 MM |
Imprint(s) | L490 |
Score | 1 |
Product Packages
NDC Code 0113-1412-71
Package Description: 1 BOTTLE in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE
Product Details
What are Good Sense Naproxen Sodium Active Ingredients?
- NAPROXEN SODIUM 220 mg/1 - An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.
Good Sense Naproxen Sodium Active Ingredients UNII Codes
- NAPROXEN SODIUM (UNII: 9TN87S3A3C)
- NAPROXEN (UNII: 57Y76R9ATQ) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 849574 - naproxen sodium 220 MG Oral Tablet
- RxCUI: 849574 - naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet
Good Sense Naproxen Sodium Inactive Ingredients UNII Codes
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Pharmacologic Class(es)
* Please review the disclaimer below.
Good Sense Naproxen Sodium Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Active Ingredient (In Each Tablet)
Naproxen sodium 220 mg
(naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever/fever reducer
Uses
• temporarily relieves minor aches and pains due to:• headache• minor pain of arthritis• muscular aches• backache• menstrual cramps• toothache• the common cold• temporarily reduces fever
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• 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
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:
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
• 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• you have problems or serious side effects from taking pain relievers or fever reducers
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 naproxen 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• 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
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.
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).
Directions
• do not take more than directed• the smallest effective dose should be used• drink a full glass of water with each dose• take 1 tablet every 8 to 12 hours while symptoms last• for the first dose you make 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• ask a doctor
Adults and children 12 years and older | |
Children under 12 years |
Other Information
• each tablet contains: sodium 21 mg• store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
Inactive Ingredients
FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Strength To Last 12 Hours
Naproxen Sodium Tablets, 220mg
Actual Size
Pain Reliever
Fever Reducer
(NSAID)
HEADACHE PAIN
For Temporary Relief of Headache Pain
Compare to active ingredient of Aleve® Headache Pain
50 Tablets
* Please review the disclaimer below.