Label: EQUATE ALLERGY AND CONGESTION RELIEF- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

  • NDC Code(s): 49035-643-46, 49035-643-60
  • Packager: Wal-Mart Stores Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 6, 2020

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

  • Active ingredients (in each tablet)

    Loratadine 5 mg

    Pseudoephedrine sulfate 120 mg

  • Purpose

    Antihistamine

    Nasal decongestant

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    sneezing
    itchy, watery eyes
    runny nose
    itching of the nose or throat
    temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
    reduces swelling of nasal passages
    temporarily relieves sinus congestion and pressure
    temporarily restores freer breathing through the nose
  • Warnings

    Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients
    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 you have

    heart disease
    thyroid disease
    high blood pressure
    diabetes
    trouble urinating due to an enlarged prostate gland
    liver or kidney disease. Your doctor should determine if you need a different dose.

    When using this product do not take more than directed.

    Taking more than directed may cause drowsiness.

    Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.
    symptoms do not improve within 7 days or are accompanied by a fever
    nervousness, dizziness or sleeplessness occurs

    If pregnant or breast-feeding,

    ask a health professional before use.

    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 divide, crush, chew or dissolve the tablet

    adults and children 12 years and over

    1 tablet every 12 hours; not more than 2 tablets in 24 hours

    children under 12 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

  • Other information

    each tablet contains: calcium 25 mg
    do not use if blister unit is broken or torn
    store between 20° to 25°C (68° to 77°F)
    keep in a dry place
  • Inactive ingredients

    croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

    Questions or comments?

    1-888-287-1915

  • Package/Label Principal Display Panel

    Compare to Claritin-D® 12 Hour Extended Release Tablets active ingredients

    NON-DROWSY*

    Allergy & Congestion Relief

    Pseudoephedrine Sulfate 120 mg/Loratadine 5 mg

    Extended Release Tablets

    Nasal Decongestant/Antihistamine

    INDOOR AND OUTDOOR ALLERGIES

    12 HOUR

    Relief of:

    Nasal and sinus congestion due to colds or allergies

    Sneezing

    Runny nose

    Itchy, watery eyes

    Itchy throat or nose due to allergies

    10 EXTENDED RELEASE TABLETS

    *When taken as directed. See Drug Facts Panel.

    Actual Size

    allergy and congestion relief
  • INGREDIENTS AND APPEARANCE
    EQUATE ALLERGY AND CONGESTION RELIEF 
    loratadine, pseudoephedrine sulfate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-643
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg
    PSEUDOEPHEDRINE SULFATE (UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE SULFATE120 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorWHITE (to off white) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code 7U0
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-643-4610 in 1 CARTON07/24/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:49035-643-6020 in 1 CARTON07/24/2020
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07605007/24/2020
    Labeler - Wal-Mart Stores Inc (051957769)