FDA Label for Mucus Relief Severe Congestion And Cough
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 20 ML)
- PURPOSES
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT,
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Mucus Relief Severe Congestion And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Meijer, 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.
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 a 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
- shake well before using
- mL=milliliter
- 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
anhydrous citric acid, EDTA disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough active ingredient*
Severe Congestion & Cough
Mucus Relief
Multi-Symptom Relief
Cough (Dextromethorphan HBr)
Chest Congestion & Mucus (Guaifenesin)
Stuffy Nose (Phenylephrine HCI)
Maximum Strength
Relieves:
Cough
Chest Congestion
Mucus
Stuffy Nose
- For ages 12 & over
FL OZ mL
*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the registered trademarks Mucinex® and Fast-Max®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
Package Label
Meijer Mucus Relief Severe Congestion and Cough Maximum Strength
* Please review the disclaimer below.