FDA Label for Triacting Daytime Cold Cough Childrens
View Indications, Usage & Precautions
Triacting Daytime Cold Cough Childrens Product Label
The following document was submitted to the FDA by the labeler of this product Quality Choice (chain Drug Marketing Association). 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
Purposes
Cough suppressant
Nasal decongestant
Uses
- temporarily relieves:
- nasal and sinus congestion
- cough 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.
Ask A Doctor Before Use If The Child Has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- a breathing problem such as chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
When Using This Product,
do not use more than directed.
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 (1-800-222-1222) right away.
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- shake well before using
age | dose |
children 6 to under 12 years of age | 10 mL every 4 hours |
children 4 to 5 years | 5 mL every 4 hours |
children under 4 years | do not use |
Other Information
- each 5 mL contains: sodium 2 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
acesulfame potassium, alcohol, benzoic acid, citric acid, disodium EDTA, FD&C red #40, flavor, maltitol solution, maltitol, propylene glycol, purified water, sodium citrate
Questions Or Comments?
Call 1-248-449-9300 Monday-Friday 9AM-5PM EST
Principal Display Panel
*Compare to the active ingredients in Children's Triaminic® Daytime Cold & Cough
Children's Triacting Daytime Cold and Cough
Dextromethorphan HBr
Cough Suppressant
Phenylephrine HCl
Nasal Decongestant
For Ages 4 to 11
Alcohol 0.14%
Cherry Flavor
FL OZ (mL)
*This product is not manufactured or distributed by Novartis Consumer Healthcare, distributors of Children's Triaminic Day Time Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by C.D.M.A., Inc.©
43157 W. Nine Mile
Novi, MI 48376-0995
www.qualitychoice.com
Questions: 248-449-9300
Package Label
Quality Choice Children's Triacting Daytime Cold & Cough Cherry Liquid
* Please review the disclaimer below.