Label: MAXI-TUSS PE MAX- guaifenesin 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 25, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL teaspoonful) Purpose
    Guaifenesin 100 mg Expectorant
    Phenylephrine HCl 5 mgNasal Decongestant
  • Uses

    temporarily relieves

    • Nasal congestion due to the common cold
    • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • 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
    • thyroid disease
    • high blood pressure
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
    • cough that occurs with too much phlegm (mucus)

    Stop use and ask a doctor if

    • nervousness, dizziness, or sleeplessness occur
    • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

    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 12 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 6 teaspoonfuls in 24 hours, 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) [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 58605-315-16

    Maxi-Tuss PE Max

    Expectorant ◾ Nasal Decongestant

    Sugar Free ◾ Alcohol Free ◾ Dye Free

    Each teaspoonful (5 mL) for oral administration
    contains:
    Guaifenesin 100 mg
    Phenylephrine HCl 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 PE MAX 
    guaifenesin and phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58605-315
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
    Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 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:58605-315-16473 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(58605-315)
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