CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]

CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [GENOMMA LAB USA, INC.]
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NDC 50066-519-24
Set ID 85fe6f0f-41c8-44d3-a34a-355938da5f72
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 10 mL = 2 teaspoonful)

    Acetaminophen 325 mg
    Dextromethorphan HBr 10 mg
    Guaifenesin 200 mg
    Phenylephrine HCL 5 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 loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • Warnings

    Liver warning: This product cantains acetaminophen. Severe liver damage may occur if your child takes

    • more tha 5 doses in 24 hours which is the maxium daily amount
    • with other drugs containing acetaminophen

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

    • skin reddening
    • blisters
    • rash

    If skin reaction occurs, stop use and seek medical help 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 vomitting, consult a doctor promptly.

  • Do not use

    • with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug containd acetaminophen, ask a doctor or pharmacist
    • for a child who is 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 an MAOI drug. If you do not know if ask a doctor or pharmacist beforre giving this product.
  • Ask a doctor before use if the child has

    • liver disease
    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • persistant or chronic cough such as occurs with asthma
    • cough that occurs with too much phlegm (musus)
  • Ask a doctor or pharmacist before use if the child is

    taking the blood thinning drug warfarin.

  • When using this product

    • do not exceed recommended dose ( see overdose section).
  • Stop use and ask a doctor if

    • nervousness, dizziness or sleeplessness occur
    • redness or swelling is present
    • pain, nasal congestion or cough gets worse or lasts more than 5 days
    • new symptoms
    • fever gets worse or lasts more than 3 days
    • cough comes back, or occurs with rash or headache that lasts

    These could be signs of a serious condition.

  • Keep out of reach of children.

    Keep out of reach of children.

  • Overdose warning

    Taking more than the recommended dose (overdose) may cause liver damage.

    In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
    Quick medical attentioni is critical even if you do not notice any signs or symptoms.

  • Directions

    • do not give more than directed
      (see Overdose warning)
    • product not labeled with directions for adult use
    • do not give more than 5 doses in any 24-hour period
    • do not give for more than 5 days unless directed by a doctor
    • measure only with dosing cup provided
    • dose as follows or as directed by a doctor
    • mL = milliliter; tsp - teaspoonful

    Age                                                                    dose

    Children 6 to under 12 years of age                     10 mL or 2 tsp every 4 hours

    Children under 6 years of age                               do not use

  • Other information

    • each 10 mL contains: sodium 6 mg
    • store between 20-25°C (68-77°F)
    • do not refrigerate
    • dosing cup provided
    • keep carton for complete Drug facts
  • 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, orbitol, sucralsoe, xanthan gum

  • Questions?

    Call 1-877-99-GENOMA (43666)

  • Children's Tukol Multi-Symptom Cold & Flu product label

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

    Children's Tukol®

    Acetaminophen/Guaifenesin/Dextromethorphan HBr/Phenylephrine HCL
    Pain Reliever/Fever Reducer/Expectorant/Cough Suppressant/Nasal Congestion

    NEW!

    Multi-Symptom Cold & Flu

    Ages 6-11

    Fever•Sore Throat•
    Stuffy Nose
    Cough•Phlegm

    BERRY flavor

    4 FL OZ  (118 mL)

    Distributed By
    Genomma Lab USA Inc. Houston, TX 77027

    BX-057

    Lot:

    Exp:

    AptaPharmaTukol ChildMS ColdFlu 519

    AptaPharmaTukol ChildMS ColdFlu 519 1

  • INGREDIENTS AND APPEARANCE
    CHILDRENS TUKOL MULTI-SYMPTOM COLD AND FLU 
    acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-519
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 10 mL
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
    GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 10 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg  in 10 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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-519-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34105/04/2016
    Labeler - Genomma Lab USA, Inc. (832323534)
    Registrant - AptaPharma Inc. (790523323)
    Establishment
    NameAddressID/FEIBusiness Operations
    AptaPharma Inc.790523323manufacture(50066-519)

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