Label: LEADER ALLERGY RELIEF D12- loratadine, pseudoephedrine sulfate tablet, film coated, extended release

  • NDC Code(s): 70000-0504-1, 70000-0504-2, 70000-0504-3
  • Packager: Cardinal Health 110, LLC. dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated June 17, 2021

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  • 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?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Non-Drowsy* | 12 Hour

    Allergy Relief D-12

    Pseudoephedrine Sulfate, 120 mg | Loratadine, 5 mg

    Extended-Release Tablets

    Nasal Decongestant | Antihistamine

    Allergy and Congestion

    Indoor and Outdoor Allergies

    Relief of: - Nasal and Sinus Congestion Due to Colds or Allergies

    Sneezing – Runny Nose – Itchy, Watery Eyes

    Itchy Throat or Nose Due to Allergies

    COMPARE TO CLARITIN-D® 12 HOUR EXTENDED RELEASE TABLETS active ingredients

    *When Taken as Directed. See Drug Facts Panel.

    10 EXTENDED RELEASE TABLETS

    Actual Size

    100% Money Back Guarantee

    Allergy Relief D-12 Carton Image 1
    Allergy Relief D-12 Carton Image 2
  • INGREDIENTS AND APPEARANCE
    LEADER ALLERGY RELIEF D12 
    loratadine, pseudoephedrine sulfate tablet, film coated, extended release
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0504
    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:70000-0504-330 in 1 CARTON01/09/2020
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:70000-0504-220 in 1 CARTON01/09/2020
    21 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:70000-0504-110 in 1 CARTON01/09/2020
    31 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07605001/09/2020
    Labeler - Cardinal Health 110, LLC. dba Leader (063997360)
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