FDA Label for Mucus Relief Maximum Strength Severe Congestion And Cough
View Indications, Usage & Precautions
Mucus Relief Maximum Strength Severe Congestion And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Care One (american Sales Company). 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 20 Ml)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Purposes
Cough suppressant
Expectorant
Nasal decongestant
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
- nasal congestion due to a cold
Do Not Use
- for children under 12 years of age
- if you are now 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 taking this product.
Ask A Doctor Before Use If You Have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- 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
- nervousness, dizziness or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever
- cough comes back, or occurs with fever, rash or headache that lasts.These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
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 a 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
- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Other Information
- each 20 mL contains: sodium 17 mg
- store between 20-25°C (68-77°F). Do not refrigerate.
Inactive Ingredients
citric acid, disodium EDTA, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Principal Display Panel
Compare to the Active ingredients in Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough*
SEVERE CONGESTION & COUGH
MUCUS RELIEF
Cough Suppressant - Dextromethorphan HBr
Expectorant - Guaifenesin
Nasal Decongestant - Phenylephrine HCl
Quick Relief
Controls Cough,
Clears Nasal & Chest Congestion,
Thins & Loosen Mucus
For Ages 12+
MAXIMUM STRENGTH
FL OZ (mL)
Questions or comments? Call 1-877-753-3935 Mondy-Friday 9AM-5PM EST
DISTRIBUTED BY:
FOODHOLD U.S.A LLC
LANDOVER , MD 20785
1-877-846-9949
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.
Package Label
CAREONE Mucus Relief Severe Congestion & Cough
* Please review the disclaimer below.