FDA Label for Severe Congestion And Cough Relief
View Indications, Usage & Precautions
Severe Congestion And Cough Relief Product Label
The following document was submitted to the FDA by the labeler of this product Safeway. 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
Purpose
Cough suppressant
Expectorant
Nasal decongestant
Uses
- helps loosen phelgm (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 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
Otc - Keep Out Of Reach Of Children
Warnings
Do not use
- for children under 12 years of age
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for 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 rash or persistent headache. 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 right away.
Directions
- do not take more than 6 doses in 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
- Adults and children 12 years 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 20 mg
- store between 15-30oC(59-86oF)
- do not refrigerate
- dosing cup provided
Inactive Ingredients
citric acid anhydrous, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum
Principal Display Panel
compare to Mucinex Fast-Max Severe Congestion and Cough active ingredients
Maximum Strength severe congestion and cough relief
Dextromethorphan HBr 20 mg - cough suppressant
Guaifenesin 400 mg - expectorant
Phenylephrine HCl 10 mg - nasal decongestant
Relieves nasal and chest congestion,
Soothes cough,
Thins and loosens mucus
for ages 12 plus
6 fl oz (177 mL)
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