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  5. Label Information: Naproxen

FDA Label for Naproxen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. STORAGE
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. HOW SUPPLIED
    18. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Naproxen Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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 (In Each Tablet)



Naproxen sodium 220 mg
(Naproxen 200 mg) (NSAID)*

*nonsteroidal anti-inflammatory drug


Purpose



Pain reliever/ fever reducer


Uses



temporarily relieves minor aches and pain due to:

  • backache
  • muscular aches
  • minor pain of arthritis
  • menstrual cramps
  • headache
  • 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

    • 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



  • under a doctor's care for any serious condition
  •   taking any other drug

When Using This Product



  • take with food or milk if stomach upset occurs


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 a stomach pain that dose not get better

      • you have symptoms of heart problems or stroke

        •  leg swelling  chest pain
         slurred speech  trouble breathing
         weakness in one part or side of body

        • 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


Otc - Pregnancy Or Breast Feeding



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



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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


Storage



  • Store at 20-25 oC (68-77 oF). Avoid high humidity and excessive heat above 40 0C (104 0F)

Other Information



  • each tablet contains: sodium 20 mg


Inactive Ingredients



croscarmellose sodium, FD&C blue #2 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl
alcohol, povidone, silicon dioxide, talc, titanium dioxide


Questions Or Comments?



Call 1-800-540-3765


How Supplied



NDC: 71335-1282-1: 20 Tablets in a BOTTLE

NDC: 71335-1282-2: 30 Tablets in a BOTTLE

NDC: 71335-1282-3: 40 Tablets in a BOTTLE

NDC: 71335-1282-4: 50 Tablets in a BOTTLE

NDC: 71335-1282-5: 60 Tablets in a BOTTLE

NDC: 71335-1282-6: 14 Tablets in a BOTTLE

NDC: 71335-1282-7: 100 Tablets in a BOTTLE

NDC: 71335-1282-8: 90 Tablets in a BOTTLE

NDC: 71335-1282-9: 24 Tablets in a BOTTLE


Package Label.Principal Display Panel



Naproxen Sodium 220mg Tablet

Label - lbl713351282

Label - lbl713351282


* Please review the disclaimer below.