TRIAMINIC Childrens Cold and Allergy

Dosage form: syrup
Ingredients: CHLORPHENIRAMINE MALEATE 1mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Novartis Consumer Health, Inc.
NDC Code: 0067-6346

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 Facts

Active ingredient

Chlorpheniramine maleate 1 mg

Phenylephrine HCl 2.5 mg

Purpose

Antihistamine

Nasal decongestant

Uses
  • temporarily relieves

    • itchy, watery eyes • runny nose • itchy nose or throat

    • sneezing • nasal and sinus congestion 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.
  • 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

• a breathing problem such as asthma or 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
  • marked drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness
  • excitability may occur, especially in children

Stop using this product
  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days or occur with a fever. 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.
AgeDose
Children under 4 years of agedo not use
children 4 to under 6 years of agedo not use unless directed by a doctor
children 6 to under 12 years of age2 teaspoonfuls (10 mL)

Other information
  • each teaspoonful contains: sodium 3 mg  
  • store at controlled room temperature  20-25°C (68-77°F)

Inactive ingredients

acesulfame K, benzoic acid, citric acid, edetate disodium, FD&C yellow #6, flavors, maltitol solution, purified water, sodium citrate

Questions or comments?

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

Additional information

Child-Resistant Safety Cap. Tamper Evident Feature: Do not use if safety seal imprinted with “Triaminic” around the bottle cap is broken or missing.

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

Trusted by Parents for over 50 years. (Depending on space availability)

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. (Depending on space availability)

Distr. by: Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622 ©2008 2004346

Package/Label Principal Display Panel

TRIAMINIC  CHILDRENS COLD AND ALLERGY
chlorpheniramine maleate, phenylephrine hcl syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-6346
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
BENZOIC ACID 
EDETATE DISODIUM 
FD&C YELLOW NO. 6 
MALTITOL 
SODIUM CITRATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:0067-6346-041 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/26/2008
Labeler - Novartis Consumer Health, Inc. (879821635)
Establishment
NameAddressID/FEIOperations
Novartis Consumer Health129836151MANUFACTURE, ANALYSIS

Revised: 04/2011
 
Novartis Consumer Health, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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