Label: MAXI-TUSS TR- pseudoephedrine hydrochloride and 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 June 23, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL teaspoonful)Purpose
    Pseudoephedrine HCl 30 mgNasal Decongestant
    Triprolidine HCl 1.25 mgAntihistamine
  • Uses

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

    • runny nose
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • nasal congestion
    • reduces swelling of nasal passages
  • 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
    • glaucoma
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes mellitus
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

    When using this product

    • excitability may occur, especially in children
    • may cause drowsiness
    • alcohol, sedatives and tranquilizers may increase drowsiness
    • avoid alcoholic beverages
    • use caution 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 accompanied by fever
    • new symptoms occur

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

    Keep out of 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 over:2 teaspoonfuls (10 mL) every 4-6 hours, not to exceed 8 teaspoonfuls in 24 hours
    Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4-6 hours, not to exceed 4 teaspoonfuls in 24 hours
    Children under 6 years of age:Consult a physician
  • Other information

    Store at 59°-86°F (15°-30°C) [see USP Controlled Room Temperature]

  • Inactive ingredients

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

  • Questions or comments?

    Call 352.754.8587

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 58605-305-16

    Maxi-Tuss TR

    Nasal Decongestant ◾ Antihistamine

    Sugar Free ◾ Alcohol Free ◾ Dye Free

    Each teaspoonful (5 mL) for oral administration
    contains:
    Pseudoephedrine HCl
    30 mg
    Triprolidine HCl
    1.25 mg

    Bubblegum Flavor

    Tamper evident by foil seal under cap.
    Do not use if foil seal is broken or missing.

    Manufactured for:
    MCR American Pharmaceuticals, Inc.
    Brooksville, FL 34604

    16 fl oz (473 mL)

    Principal Display Panel - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MAXI-TUSS TR 
    pseudoephedrine hydrochloride and triprolidine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-305
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) Pseudoephedrine Hydrochloride30 mg  in 5 mL
    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)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    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:58605-305-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34108/01/2020
    Labeler - MCR American Pharmaceuticals, Inc. (783383011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MCR American Pharmaceuticals, Inc.783383011MANUFACTURE(58605-305)
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