Label: ANA-DENT PAIN RELIEF- naproxen sodium tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 18, 2020

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

  • Drug Facts

  • Active ingredient (in each tablet)

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

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain reliever/ fever reducer

  • INDICATIONS & USAGE

    Uses ■ temporarily relieves minor aches and pain due to: ■ headache ■ muscular aches ■ toothache ■ the common cold ■ backache ■ menstrual cramps ■ minor pain of arthritis

    ■ temporarily reduces fever

  • Warnings

    Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: ■ shock ■ facial swelling ■ asthma (wheezing) ■ hives ■ skin reddening ■ blisters ■ rash

    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

    ■ have had stomach ulcers or bleeding problems

    ■ take blood thinning (anticoagulant) or steroid drug

    ■ are age 60 or older

    ■ take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

    ■ take more or for a longer time than directed

    ■ have 3 or more alcoholic drinks every day while using this product.

    Do not use ■ right before or after heart surgery ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer

    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 asthma

    ■ you have high blood pressure, heart disease, liver cirrhosis or kidney disease

    ■ you have a 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

    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.

  • DOSAGE & ADMINISTRATION

    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 to12 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 at 20°-25°C (68°-77°F). Avoid high humidity and excessive heat above 40°C (104°F)

    ■ see end flap for expiration date and lot number

  • INACTIVE INGREDIENT

    Inactive ingredients colloidal silicon dioxide, FD & C Blue#2 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide, talc

  • Questions or comments?

    Call 1-888-779-2877 M-F 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

    For toothaches

    KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

    Distributed by Belmora LLC, 2011 Crystal Dr. Suite 400 Arlington, VA 22202

    www.anadentusa.com

    Made in India

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Packaging

    Flx701

  • INGREDIENTS AND APPEARANCE
    ANA-DENT PAIN RELIEF 
    naproxen sodium tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:27854-701
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN220 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeROUND (Circular) Size10mm
    FlavorImprint Code J;67
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:27854-701-011 in 1 CARTON05/15/2020
    124 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20549705/15/2020
    Labeler - Belmora LLC (112753244)