Label: NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS- naproxen sodium and pseudoephedrine hydrochloride tablet, extended release

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

Drug Label Information

Updated October 8, 2024

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

  • Active ingredients (in each caplet)

    Naproxen sodium USP 220 mg (naproxen 200 mg) (NSAID)*
    Pseudoephedrine Hydrochloride USP 120 mg, extended-release

    *nonsteroidal anti-inflammatory drug

  • Purposes

    Pain reliever/fever reducer

    Nasal decongestant

  • Uses

    temporarily relieves these cold, sinus, and flu symptoms:
     

    • sinus pressure
    • minor body aches and pains
    • headache
    • nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose)
    • 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
    • in children under 12 years of age
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • 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, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, 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 aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin
    • 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
    • redness or swelling is present in the painful area
    • any new symptoms appear
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing or the caplet feels stuck in your throat
    • you get nervous, dizzy, or sleepless
    • nasal congestion lasts more than 7 days
  • If pregnant or breast-feeding,

    ask a health professional before use. It is especially important not to use naproxen sodium at 20 weeks or later in 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
    • swallow whole; do not crush or chew
    • drink a full glass of water with each dose
    • adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours
    • children under 12 years: do not use
  • Other information

    • each caplet contains: sodium 22 mg
    • store at 20° to 25°C (68° to 77°F)
    • store in a dry place
    • FDA approved dissolution test specifications differ from USP.
  • Inactive ingredients

    Colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc and titanium dioxide.

  • Questions or comments?

    call 1 (855) 874-0970 (Monday – Friday 8A to 5P EST)

    DISTRIBUTED BY:
    Vespyr Brands®, LLC.,
    East Windsor NJ 08520
    © 2024 Vespyr Brands®, LLC.
    All rights reserved
    Contac® is a registered trademark
    of Vespyr Brands®, LLC.
    www.contac.com

    Made in India

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 220 mg / 120 mg 24 Caplets (Capsule-Shaped Tablets) Blister Carton Label

    NDC 71179-816-24

    12
    HOUR

    CONTAC-D
    COLD & SINUS

    Naproxen Sodium 220 mg 
    & Pseudoephedrine HCL 120 mg


    Pain Reliever/Fever Reducer (NSAID)
    & Nasal Decongestant


    MAXIMUM STRENGTH

    • Headache, Fever, Sore Throat, Body Aches
    • Sinus/Nasal Congestion & Pressure

    24 EXTENDED-RELEASE CAPLETS

    Naproxen Figure

  • INGREDIENTS AND APPEARANCE
    NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS 
    naproxen sodium and pseudoephedrine hydrochloride tablet, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71179-816
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ) NAPROXEN SODIUM220 mg
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)  
    MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    POVIDONE K30 (UNII: U725QWY32X)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (White to off-white) Scoreno score
    ShapeCAPSULE (Modified Capsule Shaped) Size17mm
    FlavorImprint Code L95
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71179-816-243 in 1 CARTON08/07/2024
    18 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21136008/07/2024
    Labeler - VESPYR BRANDS, INC. (118094893)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(71179-816) , MANUFACTURE(71179-816)