Label: LORTUSS LQ- doxylamine succinate, pseudoephedrine 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

    LORTUSS LQ- doxylamine succinate, pseudoephedrine 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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    LORTUSS LQ LIQUID

    Drug Facts

  • Active ingredients

    (in each 5 mL teaspoonful) Doxylamine Succinate 6.25 mg Pseudoephedrine Hydrochloride 30 mg

  • Purpose

    Antihistamine Decongestant

  • Uses

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

    • runny nose
    • itching of the nose or throat itchy, watery eyes
    • nasal congestion
    • reduces swelling of nasal passage
  • Warnings

    Do not exceed recommended dosage.

    Do not use this product

    • 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

    a breathing problem such as emphysema or chronic bronchitis especially in children glaucoma

    trouble urinating due to an enlarged prostate gland heart disease

    high blood pressure thyroid disease diabetes mellitus

    Ask a doctor or pharmacist before use if you are

    now taking sedatives or tranquilizers.

    When using this product

    • may cause excitability especially in children
    • may cause marked 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

    • nervousness, dizziness, or sleeplessness occur
    • symptoms do not improve within 7 days or are accompanies by fever
    • 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:
    		2 teaspoonfuls (10 mL) every 6 hours, not to exceed 8 teaspoonfuls in 24-hour period or as directed by a doctor.
    Children 6 to under
    12 years of age:
    		1 teaspoonful (5 mL) every 6 hours, not to exceed
    4 teaspoonfuls 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

    Citric Acid, Glycerin, Grape Flavor, Methylparaben, Monoammonium Glycyrrhizinate, Potassium Citrate, Potassium Sorbate, Propylparaben, Propylene Glycol, Purified Water, 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 70868-750-16 LORTUSS LQ

    Antihistamine / Decongestant

    Each 5 mL (1 teaspoonful) contains: Doxylamine Succinate……………6.25 mg

    Pseudoephedrine HCl……………30 mg

    Grape Flavor

    Dye Free - Sugar Free - Alcohol Free

    16 fl oz. (473 mL)

    Distributed by:

          Key Therapeutics, LLC

          Flowood, MS 39232

          Iss. 03/20

    Product Packaging NDC 70868-750-16 LORTUSS LQ Antihistamine / Decongestant Each 5 mL (1 teaspoonful) contains: Doxylamine Succinate 6.25 mg Pseudoephedrine HCl 30 mg Grape Flavor Dye Free - Sugar

  • INGREDIENTS AND APPEARANCE
    LORTUSS LQ 
    doxylamine succinate, pseudoephedrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70868-750
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 5 mL
    PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70868-750-16473 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(70868-750)
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