Label: MICLARA LQ- triprolidine hydrochloride liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 26, 2022

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  • SPL UNCLASSIFIED SECTION

    Miclara LQ- triprolidine  hydrochloride liquid

    Key Therapeutics

    Disclaimer: Most OTC drugs are not reviewed and approved by FDA; however, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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  • MICLARA LQ LIQUID

    Drug Facts

  • Active ingredients

    (in each 5 mL teaspoonful) Triprolidine HCl 1.25 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

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

    Do not exceed recommended dosage.

    Do not use this product if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • glaucoma
    • trouble urinating due to an enlarged prostate gland

     

    Ask a doctor before use

    if you are taking sedatives or tranquilizers.

    When using this product

    • may cause excitability especially in children
    • may cause drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    • new symptoms occur

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

    Keep out of the reach of children.

    In case of accidental overdose seek professional help or contact a Poison Control Center immediately.

  • Directions

    Do not exceed recommended dosage.

    Adults and children

    12 years of age and older:

    Children 6 to under 12 years of age:

    2 teaspoonfuls (10 mL) every 4 to 6 hours, not to exceed

    8 teaspoonfuls (40mL) in 24-hour

    period or as directed by a doctor.

    1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 4 teaspoonfuls (20mL) in a 24-hour period or as directed by a doctor.

    Children under 6 years of age:       Consult a doctor

  • Other information

    Store at 59° - 86°F (15° - 30°C)

  • Inactive ingredients

    Bubble gum flavor, citric acid, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose.

  • Questions? Comments?

    Serious side effects associated with use of this product May be reported to this number. Call 1-888-981-8337

    Mon - Fri (8 a.m. to 5 p.m. CST)

  • PRINCIPAL DISPLAY PANEL

    NDC 70868-730-16 Miclara LQ

    Antihistamine

    Each 5 mL (1 teaspoonful) contains: Triprolidine HCl 1.25 mg………Antihistamine

    Bubble Gum Flavor

    Dye Free - Sugar Free - Alcohol Free

    16 fl oz. (473 mL)

    Distributed by:

          Key Therapeutics, LLC

          Flowood, MS 39232

          Iss. 03/20

    PRINCIPAL DISPLAY PANEL NDC 70868-730-16 Miclara LQ Antihistamine Each 5 mL (1 teaspoonful) contains: Triprolidine HCl 1.25 mg………Antihistamine Bubble Gum Flavor Dye Free - Sugar Free - Alcoh

  • INGREDIENTS AND APPEARANCE
    MICLARA LQ 
    triprolidine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70868-730
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIPROLIDINE HYDROCHLORIDE (UNII: YAN7R5L890) (TRIPROLIDINE - UNII:2L8T9S52QM) TRIPROLIDINE HYDROCHLORIDE1.25 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70868-730-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/15/2020
    Labeler - Key Therapeutics (080318791)
    Establishment
    NameAddressID/FEIBusiness Operations
    TG United172837085manufacture(70868-730)
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