NAPROXEN SODIUM CAPLETS (NAPROXEN SODIUM) TABLET [BREEDEN BROTHERS, LLC]

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NAPROXEN SODIUM CAPLETS (NAPROXEN SODIUM) TABLET [BREEDEN BROTHERS, LLC]
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NDC 70729-003-24, 70729-003-50
Set ID 04c73d7b-ca24-45da-a395-d3b30f6c7b1e
Category HUMAN OTC DRUG LABEL
Packager Breeden Brothers, LLC
Generic Name
Product Class
Product Number
Application Number ANDA204872
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each caplet)

    Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* 
    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug

  • Uses

    _ temporarily relieves minor aches and pains due to:

    _ toothache _ muscular aches _ the common cold

    _ headache _ menstrual cramps

    _ backache _ minor pain of arthritis

    _ temporarily reduces fever

    Drug Facts (continued)

  • Warnings

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

    _ asthma (wheezing) _ skin reddening _ shock

    _ blisters _ rash _ facial swelling _ hives

    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 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 a blood thinning (anticoagulant) or steroid drug

    _ take more or for a longer time than directed

    Drug Facts (continued)

    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, or kidney disease _ you have asthma

    _ you have problems or serious side effects from taking pain relievers or fever reducers

    _ you are taking a diuretic

    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

    _ the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

    Drug Facts (continued)

    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

    _ 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 (1-800-222-1222) right away.

    Drug Facts (continued)

  • 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

  • Other information

    _ each caplet contains: sodium 20 mg

    _ TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN

    _ store at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)

    _ use by expiration date on package

    Drug Facts (continued)

  • 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?

    1-800-901-2420

    Dist. by Breeden Brothers, LLC
    Nashville, TN 37219

  • PRINCIPAL DISPLAY PANEL

    b+b
    better by giving

    PRINCIPAL DISPLAY PANEL b+b better by giving

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM CAPLETS 
    naproxen sodium tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70729-003
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code 44;604
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70729-003-2424 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    2NDC:70729-003-5050 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20487202/01/2017
    Labeler - Breeden Brothers, LLC (080131046)
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