TUKOL MAX ACTION COLD, SORE THROAT AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GENOMMA LAB USA, INC]

TUKOL MAX ACTION COLD, SORE THROAT AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GENOMMA LAB USA, INC]
PDF | XML

NDC 50066-516-25
Set ID c8eebe64-00bf-436d-a9fc-1623401bebfa
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA, Inc
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
  • Drug FactsActive ingredients(in each 20 mL)

    Acetaminophen 650 mg
    Dextromethorphan HBr 20 mg
    Guaifenesin 400 mg
    Phenylephrine HCL 10 mg

  • Purpose

    Pain reliever/fever reducer
    Cough suppressant
    Expectorant
    Nasal decongestant

  • Uses

    • temporarily relieves these common cold and flu symptoms:
    • nasal congestion
    • cough
    • minor aches and pains
    • sore throat
    • headache
    • temporarily reduces fever
    • helps to loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 4,000 mg of acetaminophen in 24 hours
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks daily while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    • skin reddening
    • blisters
    • rash

    If skin reaction occurs, stop use and seek medical attention right away.

    Sore throat warning: If sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.

  • Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatic, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping an 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

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • a breathing problem such as chronic bronchitis
    • persistent or chronic cough such as occurs with smoking, asthma chronic, bronchitis, or emphysema
    • cough that occurs with too much phlegm (mucus)
    • trouble urinating due to enlarged prostate gland
  • Ask a doctor or pharmacist before use if

    You are taking the blood thinning drug warfarin

  • When using this product

    When using this product do not use more than directed

  • Stop use and ask a doctor if

    • you get nervous, dizzy or sleepless
    • pain, nasal congestion or cough gets worse or lasts more than 7 days
    • cough comes back or occurs with fever, rash or headache that lasts
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur

    These could be signs of a serious condition.

  • If pregnant or breast-feeding

    as a health professional before use

  • Keep out of reach of children

    Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

  • Directions

    • do not take more than directed
    • Do not take more than 6 doses in any 24 hours
    • This adult strength product is not intended for use in children under 12 years of age
    • Dose as follows or as directed by a doctor
    • Use dose cup provided

    age                                                                        dose
    Adults and children
    12 years and older                                                 20 mL every 4 hours
    Children under 12 years of age                               Do not use

  • Other information

    • Each 20 mL contains: sodium 10 mg
    • store between15-30°C (59-86 °F), do not refrigerate
  • Inactive Ingredients

    Anhydrous citric acid, edetate disodium, FD&C Blue # 1, FD&C Red # 40, flavors, glycerin, propylene glycol, propyl gallate, Purified water, sodium benzoate, Sorbitol, sucralose, xanthan gum

  • Questions or comments?

    1-877-99-Genom (43666)
    Monday to Friday from 8am to 6 pm, Central time

  • Tukol MAX ACTION Cold, Sore Throat & Cough product label

    Tukol® MAX ACTION


    DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

    NEW MAX STRENGTH
    ACETAMINOPHEN/Guaifenesin/Phenylephrine HCL/Dextromethorphan HBr

    Tukol® MAX ACTION Cold, Sore Throat & Cough

    • Fever & Headache
    • Clears Nasal Congestion
    • Thins & Loosens Mucus
    • Controls Cough

    Ages/12+
    6 FL OZ (177 mL)

    Distributed by:
    Genomma Lab USA, Inc.
    Houston, TX 77027
    Box number: BX-063

    AptaPharma Tukol MaxStrengthCold 516

    AptaPharma Tukol MaxStrengthCold 516-1

  • INGREDIENTS AND APPEARANCE
    TUKOL MAX ACTION COLD, SORE THROAT AND COUGH 
    acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-516
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg  in 20 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-516-25177 mL in 1 BOTTLE; Type 0: Not a Combination Product12/16/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/16/2016
    Labeler - Genomma Lab USA, Inc (832323534)
    Registrant - AptaPharma Inc (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc790523323manufacture(50066-516) , relabel(50066-516) , repack(50066-516)

Related Drugs