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

  • NDC Code(s): 53163-104-16
  • Packager: Alternative Pharmacal Corporation
  • 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 December 23, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tsp.)              Purpose

    Dextromethorphan HBr ............... 10 mg ................ Cough Suppressant

    Guaifenesin .............................. 200 mg ................ Expectorant

    Phenylephrine HCl ..................... 5 mg ................... Nasal Decongestant

  • PURPOSE

    Purpose

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • WARNINGS

    Warnings

    Ask a doctor before use if you have

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

    When using this product, do not exceed recommended dosage

    Stop use and ask doctor if

    • you get nervous, dizzy or sleepless
    • symptoms do not get better within 7 days or are accompanied by fever
    • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headache. These could be signs of a serious condition
  • DO NOT USE


    Do not use

    • 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 you are taking a prescription drug that contains an MAOI; ask a doctor or pharmacist before taking this product -Do not use- in a child under 2 years of age
  • 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 overdose, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves nasal congestion due to the common cold and cough due to minor throat and bronchial irritation
  • DOSAGE & ADMINISTRATION

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

    adults and children 12 years of age and over
    		take 2 teaspoonfuls (10 mL) every 4 hours
    children 6 to under 12 years of age
    		take 1 teaspoonful (5 mL) every 4 hours
    children 2 years to under 6 years of age
    		take 1/2 teaspoonful (2.5 mL) every 4 hours
    children under 2 years of age
    		ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients  citric acid, cherry flavor, FD and C red No. 40, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate and sucralos

  • QUESTIONS

    Questions or comments? 1-305-403-3788

  • PRINCIPAL DISPLAY PANEL

    altipres

  • INGREDIENTS AND APPEARANCE
    ALTIPRES 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-104
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (Cherry Flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53163-104-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/01/2013
    Labeler - Alternative Pharmacal Corporation (078528214)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!