FDA Label for Triaminic Day Time Cold And Cough And Night Time Cold And Cough

View Indications, Usage & Precautions

Triaminic Day Time Cold And Cough And Night Time Cold And Cough Product Label

The following document was submitted to the FDA by the labeler of this product Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (In Each 5 Ml)



Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Diphenhydramine HCl 6.25 mg

Phenylephrine HCl 2.5 mg


Purposes



Cough suppressant

Nasal decongestant

Antihistamine/cough suppressant

Nasal decongestant


Uses



  • •temporarily relieves
    • onasal and sinus congestion
    • ocough due to minor throat and bronchial irritation as may occur with a cold
      • •temporarily relieves
        • osneezing
        • oitchy nose or throat
        • orunny nose
        • oitchy, watery eyes due to hay fever
        • onasal and sinus congestion
        • ocough due to minor throat and bronchial irritation as may occur with a cold

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.
    • •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 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
    • 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.
    • •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.

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.
  • 10 mL

    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

     
    • •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



  • •store at 20°-25°C (68°-77°F)
    • 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 red no. 40, flavors, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

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

call 1-800-452-0051


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


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.

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      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


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