FDA Label for Mucosan Severe Multi-symptom
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OVERDOSAGE
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Mucosan Severe Multi-symptom 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 20 mL) Purpose
Dextromethorphan HBr, 20 mg...........................Cough suppressant
Guaifenesin, 400 mg..........................................Expectorant
Phenylephrine HCl, 10 mg.................................Nasal decongestant
Otc - Purpose
Purposes
Cough suppressant
Expectorant
Nasal descongestant
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
- temporarily relieves these symptoms occuring with a cold:
- nasal congestion
- cough due to minor throat and bronquial irritation.
Warnings
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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 taking this product.
Otc - Ask Doctor
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.
Overdosage
Do not exceed recommended dosage.
Otc - Stop Use
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- 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 persistant headache. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health prefessional before use.
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 right away.
Dosage & Administration
Directions
- do not take more than 6 doses in any 24 hour period
- this adult strenght product is not intended for use in children under 12 years of age
- measure only wih doisng cup provided
- keep dosing cup with product
- mL=milliliter
| age | dose |
| adults and children 12 years of age and older | 20 mL every 4 hours |
| children under 1 years of age | do not use |
Other Safety Information
Other information
- each (20mL) dose contains: sodium 10 mg
- store between 15-30°C (59-86°F)
- do not refrigerate.
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, edetate disodium, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.
Otc - Questions
Questions or comments?
1-800-560-5223 Monday to Friday 9am-4pm, Eastern Time
* Please review the disclaimer below.
