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  5. Label Information: Back And Muscle Pain

FDA Label for Back And Muscle Pain

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSES
    3. USES
    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. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Back And Muscle Pain Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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


Purposes



Pain reliever/fever reducer


Uses



  • •temporarily relieves minor aches and pains 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 You Are



  • •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 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

    • 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



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


Principal Display Panel



STRENGTH TO LAST 12 HOURS

Compare to the active ingredient of Aleve® Back & Muscle Pain

BACK & MUSCLE PAIN

NAPROXAN SODIUM TABLETS, 220 mg

ACTUAL SIZE

PAIN RELIEVER/FEVER REDUCER (NSAID)

for temporary relief of minor back & muscle aches and pains

50 TABLETS


* Please review the disclaimer below.