1. Home
  2. Labeler Index
  3. Spirit Pharmaceuticals Llc
  4. 68210-0030
  5. Label Information: All Day Pain Relief

FDA Label for All Day Pain Relief

View Indications, Usage & Precautions

Table of Contents

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

All Day Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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.

Other



Drug Facts

Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

  • asthma (wheezing)
  • blisters
  • facial swelling
  • hives
  • rash
  • shock
  • skin reddening
  • If an allergic reaction occurs, stop use and seek medical help right away.

    • Stomach bleeding warning: This product contains a non steroidal anti-inflammatory drug(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

      • DISTRIBUTED BY

      SPIRIT PHARMACEUTICALS, LLC.

      RONKONKOMA, NY 11779

      MADE IN INDIA


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
  • headache
  • menstrul cramps
  • minor pain of arthritis
  • muscular aches
  • the common cold
  • toothache
  • temporarily reduces fever

Warnings



Warnings


Do Not Use



  • if you have ever had an allergic reaction to any other pain reliever / fever reducer
  • right before or after surgery

Ask A Doctor Before Use If



  • the stomach bleeding warning applies to you
  • you have a history of stomach problems,such as a heartburn
  • you have a high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic
  • you have problems or serious side effects taking pain relievers or fever reducers
  • you have asthma

Ask A Doctor Or Pharmacist Before Use If You Are



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

When Using This Product



  • take with food or milk if stomach upset occurs
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop Use And Ask A Doctor If



  • you experience any of following sign of stomach bleeding:
  • feel faint
  • vomit blood
  • have bloody or black stools
  • have stomach pain that does not get better
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • you have difficulty swallowing
  • it feel 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 profession 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 complication during the delivery.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a position 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 20 mg
  • store between 20°-25°C(68-77°F). Avoid high humidity and excessive heat above 40°C(104°F)

Inactive Ingredients



Colloidal silicon dioxide, croscarmellose sodium, FD&C Blue#2 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel - 15 Count Bottle Carton



VALUMEDS™

SEE NEW WARNINGS INFORMATION

Compare to the active ingredient

in ALEVE®*

ALL DAY PAIN RELIEF

NAPROXEN SODIUM TABLETS, USP 220 mg

PAIN RELIEVER/FEVER REDUCER (NSAID)

STRENGTH TO LAST 12 HOURS

15 TABLETS (OVAL-SHAPED)


* Please review the disclaimer below.