Label: SUNMARK ALL DAY RELIEF- naproxen sodium tablet, film coated

  • NDC Code(s): 49348-819-09, 49348-819-10
  • Packager: McKesson
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

If you are a consumer or patient please visit this version.

  • Active ingredient (in each caplet)

    Naproxen sodium 220 mg

    (naproxen 200 mg) (NSAID)*

    *nonsteroidal anti-inflammatory drug

    Close
  • Purpose

    Pain reliever/fever reducer

    Close
  • Uses

    temporarily relieves minor aches and pains due to:
    minor pain of arthritis
    muscular aches
    backache
    menstrual cramps
    headache
    toothache
    the common cold
    temporarily reduces fever
    Close
  • 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 caplet every 8 to 12 hours while symptoms last
    for the first dose you may take 2 caplets within the first hour
    do not exceed 2 caplets in any 8- to 12-hour period
    do not exceed 3 caplets in a 24-hour period

    Children under 12 years:

    ask a doctor
    Close
  • Other information

    each caplet contains: sodium 21 mg
    store at 20-25°C (68-77°F). Avoid high humidity and excessive heat above 40°C (104°F).
    Close
  • Inactive ingredients

    FD&C blue no. 2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide

    Close
  • Questions or comments?

    1-800-719-9260

    Close
  • Principal Display Panel

    COMPARE TO ALEVE® CAPLETS ACTIVE INGREDIENT

    See New Warnings Information

    all day relief

    Naproxen Sodium Tablets, 220 mg

    Pain reliever & Fever reducer (NSAID)

    STRENGTH TO LAST 12 HOURS

    GLUTEN FREE

    Actual Size

    **Capsule-Shaped Tablets

    All Day Relief Carton Image 1
    All Day Relief Carton Image 2
    Close
  • INGREDIENTS AND APPEARANCE
    SUNMARK ALL DAY RELIEF 
    naproxen sodium tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-819
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM 220 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color BLUE (Light Blue) Score no score
    Shape CAPSULE (oval) Size 12mm
    Flavor Imprint Code L368
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49348-819-09 1 in 1 CARTON
    1 50 in 1 BOTTLE
    2 NDC:49348-819-10 1 in 1 CARTON
    2 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA074661 08/11/2003
    Labeler - McKesson (177667227)
    Close