Label: HISTIACIL COUGH- dextromethorphan hydrobromide and guaifenesin capsule

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS (in each softgel)PURPOSE
    Dextromethorphan HBr 20 mgCough suppressant
    Guaifenesin 400 mgExpectorant
  • Uses

    helps loosen phlegm (mucus)

    helps thin bronchial secretions to make coughs more productive

  • 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 your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    Ask a doctor before use if you have

    cough that occurs with too much phlegm (mucus)

    cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

    Stop use and ask a doctor if

    cough lasts for more than 7 days, recurs, or is accompained by fever, rash, or persistent headache. 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

  • Overdose warning

    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 for children even if you do not notice any signs or symptoms.

  • Directions

    Do not take more than directed - See Overdose warning

    Do not use for more than 7 days.

    Do not take more than 6 doses in 24 hours

    Adults and children
    12 years of age & over     		Take 1 softgel every 4 hours with a full glass of water while symptoms persist
    Children
    under 12 years of age     		Do not use
  • Other Information

    Store at room temperature between 20-25°C (68-77°F)

    Avoid excessive heat and humidity

  • Inactive Ingredients

    FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.

  • Questions or comments?

    Call: (619) 600-5632 (Mon-Fri 9am-5pm EST)

  • SPL UNCLASSIFIED SECTION

    Exclusively distributed by:
    OPMX
    Chula Vista, CA 91910

  • PRINCIPAL DISPLAY PANEL - 20 Softgel Blister Pack Box

    NDC 69729-000-00

    Histiacil NF

    Dextromethorphan HBr
    Guaifenesin

    Cough

    Expectorant & Cough Supressant

    • Controls cough
    • Thins & loosens mucus
    • Easy to swallow

    20 Softgels Box

    PRINCIPAL DISPLAY PANEL - 20 Softgel Blister Pack Box
  • INGREDIENTS AND APPEARANCE
    HISTIACIL COUGH 
    dextromethorphan hydrobromide and guaifenesin capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-108
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeOVALSize20mm
    FlavorImprint Code 781
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-108-202 in 1 BOX03/01/2022
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01203/01/2022
    Labeler - OPMX LLC (029918743)
    Registrant - Strive Pharmaceuticals Inc. (474844049)
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