Label: TRIAMINIC NIGHT TIME COLD AND COUGH- diphenhydramine hcl, phenylephrine hcl syrup

  • NDC Code(s): 0067-8106-04
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 December 11, 2020

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  • 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
    •
    sneezing
    •
    itchy nose or throat
    •
    runny nose
    •
    itchy, watery eyes due to hay fever
    •
    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.
    •
    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

    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.

  • Principal Display Panel

    NDC 0067-8106-04

    Ages 6 to 11 years

    Children’s Triaminic® Syrup

    Night Time Cold & Cough

    Diphenhydramine HCl (Antihistamine/Cough Suppressant)

    Phenylephrine HCl (Nasal Decongestant)

    •
    Cough Relief
    •
    Runny, Stuffy Nose
    •
    Itchy Throat

    Grape 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

    Night Time Cold & Cough

    •
    Cough Relief
    •
    Runny, Stuffy Nose
    •
    Itchy Throat

    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

    12682

    12682_Triaminic NT CC_4oz.JPG
  • INGREDIENTS AND APPEARANCE
    TRIAMINIC  NIGHT TIME COLD AND COUGH
    diphenhydramine hcl, phenylephrine hcl syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem 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 Product10/15/2012
    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)
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