Label: AQUANAZ- dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet

  • NDC Code(s): 29978-587-01
  • Packager: Capital Pharmaceutical, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Aquanaz Drug Facts.

  • Active Ingredient.

    Dextromethorphan HBr 15mg.

  • Purpose.

    Cough Suppressant.

  • Active Ingredient.

    Guaifenesin 400mg.

  • Purpose.

    Expectorant.

  • Active Ingredient.

    Phenylephrine HCL 10mg.

  • Purpose.

    Nasal Decongestant.

  • Uses:

    Temporally relieves these symptoms accruing with a cold nasal decongestion cough due to minor throat and bronchial irritation—helps loosen phlegm (mucus) and thins bronchial secretions to drain bronchial tubes.

  • Warnings: When using this product do not exceed recommended dose.

    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 MAOI drugs. If you do not know if your prescription drug contains an MAOI. Consult a doctor or pharmacist before taking this product.

  • Stop use and ask a doctor if:

    Symptoms do not improve--new symptoms occur--redness or swelling is present--nervousness, dizziness or sleeplessness occurs--symptoms do not improve within 7 days or are accompanied by fever--cough persists for more than 1 week, tends to recur, or is a accompanied by fever, rash or persistent headache. A persistent cough may be the sign of a serious condition.

  • Ask a doctor before use if you have:

    Heart disease--high blood pressure--thyroid disease—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 or where cough is accompanied by excessive phlegm (mucus)

  • Directions:

    Adults and children 12 years and older: Take 1tablet every 4-6 hours as needed, do not exceed 4 tablets in 24hours, or as directed by a doctor.

    Children 6-12 years: Take ½ tablet every 4-6 hours as needed, do not exceed 2 tablets in 24 hours, or as directed by a doctor.

  • If pregnant or breast-feeding baby,

    ask a health care professional before use.

  • KEEP OUT OF REACH OF CHILDREN.

    In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

  • Inactive Ingredients:

    F&C Blue #2 Microcrystalline Celulose, Silicone Dioxide, Stearic Acid.

  • Other Information:

    Do not use if there are signs of tampering—Store at controlled room temperature 15deg-30degC (59-86degF)

  • PRINCIPAL DISPLAY PANEL

    NDC 29978-587-01
    NEW
    Aquanaz
    TABLETS
    TRIPLE COMBINATION RELIEF:
    Cough Suppressant: Dextromethorphan HBR 15 MG
    Expectorant: Guaifenesin 400 MG
    Decongestant: Phenylephrine HCL 10 MG
    100 Tablets
    PRINCIPAL DISPLAY PANEL NDC 29978-587-01 NEW Aquanaz TABLETS TRIPLE COMBINATION RELIEF: Cough Suppressant: Dextromethorphan HBR 15 MG Expectorant: Guaifenesin 400 MG Decongestant: Phenylephrine HCL 10

  • INGREDIENTS AND APPEARANCE
    AQUANAZ 
    dextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochloride tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29978-587
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Colorblue (light blue) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code PAC3
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29978-587-01100 in 1 BOTTLE; Type 0: Not a Combination Product03/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/10/2015
    Labeler - Capital Pharmaceutical, LLC (831545541)
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