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Triaminic

Novartis Consumer Health, Inc.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purpose

Cough suppressant

Nasal decongestant 

Triaminic 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 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
  • Age Dose
    children under 4 years of age do not use
    children 4 to under 6 years of age 1 teaspoonful (5 mL)
    children 6 to under 12 years of age 2 teaspoonfuls (10 mL)

Triaminic Other information

  • each teaspoonful contains: sodium 2 mg
  • store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

acesulfame K, benzoic acid, citric acid, edetate disodium, FD&C red #40, flavors, maltitol solution, propylene glycol, purified water, sodium citrate

Questions or comments?

call 1-800-452-0051 24 hours a day, 7 days a week

Additional Information Listed on Other Panels

See New Directions and Warnings Information 

Children’s

Triaminic®

Syrup

Day Time Cold & Cough

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

  • Stuffy Nose
  • Cough

PARENTS: Learn about teen medicine abuse. www.StopMedicineAbuse.org

 

Child-Resistant Safety Cap

TAMPER-EVIDENT FEATURE:

DO NOT USE IF SAFETY SEAL IMPRINTED WITH “TRIAMINIC” AROUND BOTTLE CAP IS BROKEN OR MISSING.

 

Triaminic® Has More Ways to Help Kids Feel Better!

Great Tasting Liquids

  • Free Dosage Cup (enclosed)
  • Alcohol Free

Fast-Dissolving Softchews®

  • Great Taste

Convenient Thin Strips®

  • Melts in an Instant
  • Easy to Give/Easy to Take
  • No Mess Dosing

information plus hS-987

24 hours a day, 7 days a week

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

Trusted by Parents for over 50 years.

What You Need to Make Your Child Feel Better!  

For more information plus helpful tips visit www.triaminic.com or call The Triaminic Clinic®

1-800-KIDS-987 24 hours a day, 7 days a week.

Distr. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©20xx

Principal Display - Cherry

Triaminic
Children's Triaminic Day Time Cold & Cough Syrup

Triaminic

Dextromethorphan HBr, Phenylephrine HCl SYRUP

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0067-6345
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 5 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
BENZOIC ACID
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FD&C RED NO. 40
CHERRY
MALTITOL
propylene glycol
water
SODIUM CITRATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 118 in 1 BOTTLE, PLASTIC
2 NDC:0067-6345-04 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2011-11-01


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Be sure to consult your doctor before taking any medication!
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