1. Home
  2. Labeler Index
  3. Camber Consumer Care Inc
  4. 69230-329
  5. Label Information: Naproxen Sodium

FDA Label for Naproxen Sodium

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. PREGNANCY/BREASTFEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Naproxen Sodium Product Label

The following document was submitted to the FDA by the labeler of this product Camber Consumer Care Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient(S)



(in each tablet)
Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*                                                          
*nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/ fever reducer
               



Use(S)




• temporarily relieves minor aches and pains due to:
   • minor pain of arthritis
   • muscular aches
   • backache
   • headache
   • the common cold
   • menstrual cramps 
   • toothache
• 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  
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.


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


Pregnancy/Breastfeeding




If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use naproxen sodium 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.


Keep Out Of Reach Of Children




In case of overdose, get medical help or contact a Poison Control Center right away.


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

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




corn starch, FD&C blue #2, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, talc and titanium dioxide.


Questions Or Comments?



1-888-588-1418 (Mon - Fri 9AM - 5PM EST)
 
Do not use if bottle is open or if foil seal imprinted with "SEALED for YOUR PROTECTION" on bottle opening is missing or broken.
 

Mfg. Lic. No.: 24/MD/TS/2016/F/G


Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.


Principal Display Panel




Naproxen Sodium Round Shape 100's container Label

naproxensodium-round-100s-cont-label - naproxensodium round 100s cont label

naproxensodium-round-100s-cont-label - naproxensodium round 100s cont label



 
Naproxen Sodium Round Shape 100's container Carton Label





* Please review the disclaimer below.