FDA Label for Childrens Multi-symptom Cold
View Indications, Usage & Precautions
Childrens Multi-symptom Cold Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, 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
Guaifenesin 100 mg
Phenylephrine HCl 2.5 mg
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help your child get to sleep
- nasal congestion due to a cold
- stuffy nose
Warnings
Do not use 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 your 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
- persistent or chronic cough such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
When Using This Product
- do not use more than directed
Stop Use And Ask A Doctor If
- your child gets nervous, dizzy or sleepless
- symptoms do not get better within 7 days or occur with fever
- cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious illness.
keep out of reach of children. In case of overdose, get medical help or contact a poison control center right away.
Directions
- do not take more than 6 doses in any 24 hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
Age | Dose |
children 6 years to under 12 years | 10 mL every 4 hours |
children 4 years to under 6 years | 5 mL every 4 hours |
children under 4 years | do not use |
Other Information
- each 5 mL contains: potassium 5 mg, sodium 5 mg
- store between 15-30oC (59-86oF)
- do not refrigerate
- dosing cup provided
Inactive Ingredients
citric acid anhydrous, D&C red 33, dextrose, edetate disodium, FD&C blue 1, FD&C red 40, flavor, glycerin, methylparaben, potassium sorbate, propyl gallate, propylene glycol, propylparaben, purified water, saccharin sodium, sodium hydroxide, sorbitol solution, sucralose, xanthan gum
Questions?
1-800-824-1706 Monday - Friday 9am-4pm MST.
You may also report side effects to this phone number
Pdp
*Compare to the active ingredients in Children's MUCINEX® Multi-symptom cold
Children's Multi-symptom Cold Relief
Dextromethorphan HBr / Cough suppressant
Guaifenesin / Expectorant
Phenylephrine HCl / Nasal decongestant
Relieves:Stuffy Nose, Cough, Chest Congestion
Thins and Loosens Mucus
For Ages 4-12 Years
Ver Berry Flavor
4 FL OZ (118 mL)
* Please review the disclaimer below.