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

  • NDC Code(s): 53163-106-16
  • 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

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  • ACTIVE INGREDIENT

    Active Ingredients (in each 5 mL tsp.)              Purpose

    Dextromethorphan HBr ............... 28 mg ................ Cough Suppressant

    Guaifenesin .............................. 388 mg ................ Expectorant

    Phenylephrine HCl ..................... 10 mg ................... Nasal Decongestant

  • PURPOSE

    Purpose 

    Cough Suppressant

    Expectorant

    Nasal Decongestant

  • WARNINGS

    Warnings

    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 your doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of prostate gland
    • a cough with too much phlegm (mucus)
    • a persistent or chronic cough as occurs with smopking, asthma, chronic bronchitis, or emphysema

    Ask a doctor before use if you are taking sedatives, tranquilizers or drugs for depression or MAOI drugs.

    Stop use and ask a doctor if

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

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental overdose, seek advice of a doctor or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
    • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
    • temporarily releives nasal congestion due to the common cold.
  • DOSAGE & ADMINISTRATION

    Directions  Do not exceed more than 4 doses in 24 hours.

    Adults and children over 12 years of age                   take 1 teaspoonful (5 mL) every 6-8 hours

    Children 6 to under 12 years of age                          take 1/2 teaspoonful (2.5 mL) every 6-8 hours

    Children under 6 years of age                                   consult a doctor before use

  • INACTIVE INGREDIENT

    Inactive ingredients: Citric acid, FD&C Yellow #6, glycerin, menthol, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose

  • QUESTIONS

    Questions or comments? 1-786-507-1566

    Monday-Friday 9:00AM -5:00PM

  • PRINCIPAL DISPLAY PANEL

    igualtuss

  • INGREDIENTS AND APPEARANCE
    IGUALTUSS 
    dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53163-106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE28 mg  in 5 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN388 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53163-106-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/2014
    Labeler - Alternative Pharmacal Corporation (078528214)
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