Label: MAXI-TUSS JR- dextromethorphan hydrobromide and phenylephrine 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 24, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL teaspoonful)Purpose
    Dextromethorphan HBr 5 mgCough Suppressant
    Phenylephrine HCl 2.5 mgNasal Decongestant
  • Uses

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

    • cough due to minor throat and bronchial irritation as may occur with a cold
    • nasal congestion due to a cold, hay fever or other upper respiratory allergies
  • 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

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • cough that occurs with too much phlegm (mucus)
    • chronic cough that lasts or as occurs with asthma
    • difficulty in urination due to enlargement of the prostate gland
    • A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
    • Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.

    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 hours, not to exceed 24 teaspoonfuls in 24 hours or as directed by a doctor
    Children 6 to under 12 years of age:1 teaspoonful (5 mL) every 4 hours, not to exceed 12 teaspoonfuls in 24 hours or as directed by a doctor
    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

    Citric acid, grape flavor, 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 58605-308-16

    Maxi-Tuss Jr
    Cough Suppressant ■ Nasal Decongestant

    Sugar Free ■ Alcohol Free ■ Dye Free

    Each teaspoonful (5 mL) for oral administration
    contains:
    Dextromethorphan HBr 5 mg
    Phenylephrine HCl 2.5 mg

    Grape 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 JR 
    dextromethorphan hydrobromide and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-308
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide5 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride2.5 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
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58605-308-16473 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(58605-308)
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