TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

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  • TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]

TRIAMINIC DAY TIME COLD AND COUGH (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SYRUP [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]
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NDC 0067-8105-04
Set ID 9437b637-fb70-41dd-8ead-d79698a61e22
Category HUMAN OTC DRUG LABEL
Packager GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist
Product Number
Application Number PART341
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  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Phenylephrine HCl 2.5 mg

  • Purpose

    Cough suppressant

    Nasal decongestant 

  • Uses

    •
    temporarily relieves
    •
    nasal and sinus congestion
    •
    cough due to minor throat and bronchial irritation as may occur with a cold
  • Warnings

    Do not use

    •
    in a child under 4 years of age
    •
    in 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 the MAOI drug. If you do not know if the child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

    Ask doctor before use if the child has

    •
    heart disease
    •
    high blood pressure
    •
    thyroid disease
    •
    diabetes
    •
    cough that occurs with too much phlegm (mucus)
    •
    chronic cough that lasts, or as occurs with asthma

    When using this product

    •
    do not exceed recommended dosage

    Stop use and ask a doctor if

    •
    nervousness, dizziness or sleeplessness occurs
    •
    symptoms do not improve within 7 days or occur with a fever
    •
    cough persists for more than 7 days, comes back or occurs with a fever, rash or persistent headache. These could be signs of a serious condition.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    may be given every 4 hours. Do not give more than 6 doses in 24 hours unless directed by a doctor
    •
    use enclosed dosing cup only. Keep for use with this product only. Do not use any other dosing device.

    Age

    Dose

    children under 4 years of age

    do not use

    children 4 to under 6 years of age

    5 mL

    children 6 to under 12 years of age

    10 mL
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C red no. 40, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions or comments?

    call 1-800-452-0051

  • Principal Display Panel

    NDC 0067-8105-04

    Children's

    Triaminic®

    Syrup

    Day Time Cold & Cough

    Ages 4 to 11 Years

    Dextromethorphan HBr (Cough Suppressant)

    Phenylephrine HCl (Nasal Decongestant)

    *Stuffy Nose

    *Cough

    Cherry FLAVOR

    4 FL OZ (118 mL)

    Child-Resistant Safety Cap.

    Do not use if printed neckband is broken or missing.

    What You Need to Help Make Your Child Feel Better

    The Triaminic® brand provides a broad range of products, created with the needs of children in mind.

    Trusted by Parents for over 50 years.

    For more information plus helpful tips visit www.triaminic.com or call The Triaminic Clinic®, 1-800-KIDS-987.

    PARETNS:

    Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    Distributed by:

    GSK Consumer Healthcare, Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2016 GSK group of companies or its licensor. All rights reserved.

    12677

    Childrens Triaminic Day Time Cold & Cough Syrup 4 fl oz (118 mL) carton
  • INGREDIENTS AND APPEARANCE
    TRIAMINIC  DAY TIME COLD AND COUGH
    dextromethorphan hbr, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    MALTITOL (UNII: D65DG142WK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8105-041 in 1 CARTON10/15/2012
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    L. Perrigo Company006013346MANUFACTURE(0067-8105) , PACK(0067-8105) , LABEL(0067-8105)
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