Label: MEDIQUE LORADAMED- loratadine tablet
MEDI-FIRST PLUS ALLERY RELIEF- loratadine tablet

  • NDC Code(s): 47682-403-12, 47682-403-46, 47682-403-50, 47682-912-33
  • Packager: Unifirst First Aid Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)

    Loratadine 10 mg

  • PURPOSE

    Purpose

    Antihistamine

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves these symptoms due to hay fever or other repiratory allergies

    • runny nose
    • itchy, watery eyes
    • sneezing
    • itching of the nose or throat
  • WARNINGS

    Warnings

  • DO NOT USE

    Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

  • ASK DOCTOR

    Ask a doctor before use if you have liver or kidney diease. Your doctor should determine if you need a different dose.

  • WHEN USING

    When using this product do not take more than directed. Taking more than directed may cause drowsiness.

  • STOP USE

    Stop use and ask a doctor if

    • an allergic reaction to this product occurs. Seek medical help right away.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    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).

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children: (6 years and over)

    1 tablet daily; not more than 1 tablet in 24 hours

    Children under 6 years:

    Ask a doctor

    Consumers with liver or kidney disease:

    Ask a doctor

  • OTHER SAFETY INFORMATION

    Other information

    • sore between 68º and 77ºF (20º and 25ºC)
    • protect from excessive moisture
    • tamper evident sealed packets
    • do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients

    corn starch*, lactose monohydrate, magnesium stearate, pregelatinized corn starch*, pregelantinized starch*, sodium starch glycolate*

    * may contain

  • QUESTIONS

    Questions or comments? Call 1-800-634-7680

  • PRINCIPAL DISPLAY PANEL

    Medique®

    Loradamed

    Antihistamine • Laratadine 10 mg

    Antistaminico • Loratadina 10 mg

    24-Hour Allergy Relief

    24-horas alivio a las alergias

    Pull to Open

    Tire Para Abrir

    packet not child-resistant.

    Paquete no resistente a los ninos

    *When taken as directed. See Drug Facts panel.

    *Cuando se toma coma se indica. Ver la informacion del medicamento.

    Collect Medibucks

    See inside flap for more details

    50 Tablets (50 x 1)

    203R Medique Lor

  • PRINCIPAL DISPLAY PANEL

    Medi-First® Plus

    24-Hour Allergy Relief

    24-horas alivo a las alergias

    Laratadine/ Loratadina 10 mg

    Pull to Open

    Tire Para Abrir

    Antihistamine/Antistaminico

    Packet is not child-resistant.

    Paquete no resistente a los ninos.

    *When taken as directed. See Drug Facts panel.

    *Cuando se toma coma se indica. Ver la informacion del medicamento.

    Compare active ingredient to:

    Claritin®

    Registered Trademark of Bayer Corp.

    100 Tablets (100 x 1)

    203R MFP

  • INGREDIENTS AND APPEARANCE
    MEDIQUE LORADAMED 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-403
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-403-5050 in 1 BOX06/01/2023
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:47682-403-1210 in 1 BOX06/01/2023
    21 in 1 PACKET; Type 0: Not a Combination Product
    3NDC:47682-403-461 in 1 PACKET; Type 0: Not a Combination Product06/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072206/01/2023
    MEDI-FIRST PLUS ALLERY RELIEF 
    loratadine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47682-912
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    WATER (UNII: 059QF0KO0R)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code G;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-912-33100 in 1 BOX06/01/2023
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21072206/01/2023
    Labeler - Unifirst First Aid Corporation (832947092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prestige Packaging080667761pack(47682-403, 47682-912)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medique Products086911794pack(47682-403, 47682-912)
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