Label: ALTIPRES PEDIATRIC- dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid

  • NDC Code(s): 45737-105-16
  • Packager: Advanced Generic Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 30, 2025

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  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tsp.) Purpose

    Dextromethorphan HBr ............... 5 mg ................ Cough Suppressant

    Guaifenesin .............................. 75 mg ................ Expectorant

    Phenylephrine HCl ..................... 2.5 mg ................... Nasal Decongestant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold
    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily releives nasal congestion due to the common cold.
  • WARNINGS

    Warnings

    Do not use in a child who is 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 child's prescription drug contains an MAOI; ask your doctor or pharmacist before taking this product.

    Ask a doctor before use if your child has

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to enlargement of prostate gland
    • a cough that occurs with too much phlegm (mucus)
    • cough that lasts or is chrinic such as occurs with smoking, asthma, chronic bronchitis or emphysema.

    When using this product do not exceed recommended dosage

    Stop use and ask a doctor if

    • your child gets nervous, dizzy, or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts for more than 7 days, comes back or is accompanied with a fever, rash or persistent headache. These could be signs of serious condition.
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions Do not exceed more than 6 doses in any 24-hour period.

    AgeDose
    Adults and children 12 years of age and overtake 4 teaspoonfuls (20 mL) every 4 hours
    Children 6 to under 12 years of agetake 2 teaspoonfuls (10 mL) every 4 hours
    Children 2 to under 6 years of agetake 1 teaspoonfuls (5 mL) every 4 hours
    Children under 2 years of agedo not use

  • INACTIVE INGREDIENT

    Inactive ingredients:Artificial and natural flavors, Citric acid, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

  • QUESTIONS

    Questions or comments?1-305-403-3788

  • PRINCIPAL DISPLAY PANEL

    AltipresPed105

  • INGREDIENTS AND APPEARANCE
    ALTIPRES PEDIATRIC 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN75 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-105-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01212/01/2024
    Labeler - Advanced Generic Corporation (831762971)