Label: TRIAMINIC DAY TIME COLD AND COUGH AND NIGHT TIME COLD AND COUGH- dextromethorphan hbr, phenylephrine hcl and diphenhydramine hcl, phenylephrine hcl kit

  • 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 January 1, 2016

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  • Day Time Cold & Cough – Ages: 4 years & up

  • Active ingredients (in each 5 mL)

    Dextromethorphan HBr 5 mg

    Phenylephrine HCl 2.5 mg

  • Purposes

    Cough suppressant

    Nasal decongestant

  • Uses

    •
    temporarily relieves
    o
    nasal and sinus congestion
    o
    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 a doctor before use if your 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, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions or comments?

    call 1-800-452-0051

  • Night Time Cold & Cough – Ages: 6 years & up

  • Active ingredients (in each 5 mL)

    Diphenhydramine HCl 6.25 mg

    Phenylephrine HCl 2.5 mg

  • Purposes

    Antihistamine/cough suppressant

    Nasal decongestant

  • Uses

    •
    temporarily relieves
    o
    sneezing
    o
    itchy nose or throat
    o
    runny nose
    o
    itchy, watery eyes due to hay fever
    o
    nasal and sinus congestion
    o
    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.
    •
    with any other product containing diphenhydramine, even one used on skin
    •
    for the purpose of making your child sleepy

    Ask a doctor before use if the child has

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

    Ask a doctor or pharmacist before use if the child is

    taking sedatives or tranquilizers

    When using this product

    •
    do not exceed recommended dosage
    •
    may cause marked drowsiness
    •
    sedatives and tranquilizers may increase drowsiness
    •
    excitability may occur, especially in children

    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

    do not use unless directed by a doctor

    children 6 to under 12 years of age

    10 mL
  • Other information

    •
    each 5 mL contains: sodium 3 mg
    •
    store at 20°-25°C (68°-77°F)
  • Inactive ingredients

    acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, 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

    Children’s Triaminic® Syrup

    DAY/NIGHT VALUE PACK

    Day Time Cold & Cough

    Ages 4-11 Years

    Dextromethorphan HBr (Cough Suppressant)

    Phenylephrine HCl (Nasal Decongestant)

    •
    Stuffy Nose
    •
    Cough

    Cherry Flavor

    4 FL OZ (118 mL)

    Night Time Cold & Cough

    Ages 6 to 11 years

    Diphenhydramine HCl (Antihistamine/Cough Suppressant)

    Phenylephrine HCl (Nasal decongestant)

    •
    Cough Relief
    •
    Runny, Stuffy Nose
    •
    Itchy Throat

    Grape Flavor

    4 FL OZ (118 mL)

    8 FL OZ (236 mL) TOTAL

    Do not give both products at the same time or give more than 6 doses in total in any 24 hour period.

    Child-Resistant Safety Cap.

    Do not use if printed neckband is broken or missing.

    What You Need to help Make Your Child Feel Better

    PARENTS: Learn about teen medicine abuse

    www.StopMedicineAbuse.org

    DO NOT GIVE THE FIRST DOSE OF NIGHT TIME COLD & COUGH SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAY TIME COLD & COUGH UNLESS DIRECTED BY A DOCTOR.

    DO NOT GIVE BOTH PRODUCTS AT THE SAME TIME OR GIVE MORE THAN 6 DOSES IN TOTAL IN ANY 24 HOUR PERIOD.

    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.

    12678

    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

    12678_Triaminic Kit_8 oz.JPG
  • INGREDIENTS AND APPEARANCE
    TRIAMINIC  DAY TIME COLD AND COUGH AND NIGHT TIME COLD AND COUGH
    dextromethorphan hbr, phenylephrine hcl and diphenhydramine hcl, phenylephrine hcl kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-8112
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8112-081 in 1 CARTON; Type 0: Not a Combination Product01/01/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    TRIAMINIC  DAY TIME COLD AND COUGH
    dextromethorphan hbr, phenylephrine hcl syrup
    Product Information
    Item 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:0067-8105-04118 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
    Part 2 of 2
    TRIAMINIC  NIGHT TIME COLD AND COUGH
    diphenhydramine hcl, phenylephrine hcl syrup
    Product Information
    Item Code (Source)NDC:0067-8106
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE6.25 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 BLUE NO. 1 (UNII: H3R47K3TBD)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0067-8106-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/15/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/01/2016
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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