FDA Label for Mucosan Childrens Multi-symptom Grape
View Indications, Usage & Precautions
Mucosan Childrens Multi-symptom Grape Product Label
The following document was submitted to the FDA by the labeler of this product Menper Distributors, Inc.. 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.
Otc - Active Ingredient
Active ingredients (in each 5 mL, 1 teaspoon) Purposes
Dextromethorphan HBr, 5 mg...............................Cough suppressant
Guaifenesin, 50 mg...............................................Expectorant
Phenylephrine HCl, 2.5 mg...................................Nasal decongestant
Otc - Purpose
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- temporarily relieves these symptoms occurring with a cold:
- nasal congestion
- cough due to minor throat and bronchial irritation
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 week after stopping the MAOI drug. If you do not know if your child's prescritpion drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Otc - Ask Doctor
Ask a doctor before use if the child has
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- cough that lasts or is chronic such as occurs with asthma
- cough that occurs with too much phlegm (mucus)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the child is taking any other oral nasal decongestant or stimulant.
Overdosage
Do not exceed recommended dosage.
Otc - Stop Use
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not get better within 7 days or are accompanied by fever
- cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Dosage & Administration
Directions
- do not take more than 6 doses in any 24 hour period
- measure only with dosing cup provided
- keep dosing cup with product
- TSP=teaspoon
| age | dose |
| children 6 to under 12 years | 2 teaspoons (10mL) every 4 hours |
| children 4 to under 6 years | 1 teaspoon (5mL) every 4 hours |
| children under 4 years | do not use |
Other Safety Information
Other information
- each teaspoon (5mL) contains: sodium 3 mg
- store at 15-30°C (59-86°F). Do not refrigerate.
Inactive Ingredient
Inactive ingredients
citric acid, FD&C blue #1, FD&C red #40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Otc - Questions
Questions or comments?
1-800-560-5223 Monday to Friday 9am-4pm, Eastern Time
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