Label: GUAIFENESIN, DEXTROMETHORPHAN HBR capsule, liquid filled

  • 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 October 7, 2022

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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 looseen 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 smooking, 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 softgels 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 humiditydity

  • INACTIVE INGREDIENT

    D&C yellow No. 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

    VERSIÓN EN ESPAÑOL EN EL INTERIOR DE LA CAJA

    Tenalif - Adults
    Tesaperlas
    Expectorant & Cough Suppressant
    Dextromethorphan HBr 20 mg Guaifenesin 400 mg

  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

  • SPL UNCLASSIFIED SECTION

    Tenalif
    Adults
    Tesaperlas
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Expectorant & Cough Suppressant

  • SPL UNCLASSIFIED SECTION

    Made for:
    RRX

    Exclusively distributed by:
    OPMX
    Chula Vista, CA 91910
    Phones: 619-600-5632

    TAMPER EVIDENT:
    Do not use if package is opened or if blister unit is torn, broken or shows any sign of tampering

  • PRINCIPAL DISPLAY PANEL

    NDC 69729-783-02
    Tenalif® - Adults
    Tesaperlas

    Expectorante & Supresor de la Tos
    Expectorant & Cough Suppressant

    Controls cough
    Controla la tos

    Thins & loosens mucus
    Adelgaza y expulsa las flemas

    SOFTGELS
    Dextromethorphan HBr 20 mg / Guaifenesin 400 mg
    20 Softgels Box

    TENALIF TESAPERLAS

    TENALIF TESAPERLAS DRUGFACTS SPANISH

  • INGREDIENTS AND APPEARANCE
    GUAIFENESIN, DEXTROMETHORPHAN HBR 
    guaifenesin, dextromethorphan hbr capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-783
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN (UNII: 2G86QN327L)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Coloryellow (LIGHT YELLOW) Scoreno score
    ShapeOVAL (Oblong) Size20mm
    FlavorImprint Code 781
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69729-783-022 in 1 CARTON02/18/2019
    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 finalpart34102/18/2019
    Labeler - OPMX LLC (029918743)
    Establishment
    NameAddressID/FEIBusiness Operations
    MEDGEL PRIVATE LIMITED677385498manufacture(69729-783)
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