TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC]

TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, GELATIN COATED [GENOMMA LAB USA, INC]
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NDC 50066-601-02
Set ID ae5ce270-ca7b-4a6e-bc48-547e97db06e1
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA, Inc
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts Active ingredients

    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg

  • Purpose

    Cough Suppressant
    Expectorant

  • 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.

  • Uses

    • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
    • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • 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 more than 7 days, comes back, or is accompanied 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.

  • Directions

    • Do not take more than 12 softgels in any 24-hour period
    • This product is not intended for use in children under 12 years
    • Adults and children 12 years and over - 2 softgels every 4 hours
    • Children under 12 years of age - do not use
  • Other information

    • Store at room temperature
    • Avoid excessive heat above 40° C (104° F)
  • Inactive ingredients

    FD and C Red # 40, Gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol, Purified water, Sorbitol sorbitan solution, Titanium dioxide

  • Questions or comments?

    1-877-99 GENOM (43666)

  • Tukol Maximum Strength Cough and Mucus Relief Label

    Tukol®

    Dextromethorphan HBr-Cough suppressant / Guaifensin-Expectorant

    Relieves

    Cough
    Mucus

    Use in the morning, evening or anytime

    MAIMUM STRENGTH

    For ages 12 and over

    20 SOFTGELS

    Do not use if plastic blister is open or broken

    Made in India
    Distributed by Genomma Lab USA, Inc. Houston, TX 77027

    BX - 048


    AptaPharma TukolMS Label

    AptaPharma TukolMS1 Label

  • INGREDIENTS AND APPEARANCE
    TUKOL MAXIUM STRENGTH COUGH AND MUCUS RELIEF 
    dextromethorphan hydrobromide, guaifenesin capsule, gelatin coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-601
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SORBITAN (UNII: 6O92ICV9RU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Colorred (RED) Scoreno score
    ShapeCAPSULE (OBLONG) Size20mm
    FlavorImprint Code 601
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-601-0220 in 1 CARTON
    11 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/17/2015
    Labeler - Genomma Lab USA, Inc (832323534)
    Registrant - AptaPharma Inc (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc790523323manufacture(50066-601) , relabel(50066-601) , repack(50066-601)

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