FDA Label for Mucus Relief Severe Congestion And Cough Maximum Strength
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
Mucus Relief Severe Congestion And Cough Maximum Strength Product Label
The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals 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 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 (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 products• 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 8 mg• low sodium• store at room temperature• do not refrigerate• dosing cup provided
Inactive Ingredients
anhydrous citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavor, potassium citrate, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-866-467-2748
Principal Display Panel
DRx CHOICE®
Compare To the active Ingredients Maximum Strength Mucinex® Fast-Max™ Severe Congestion & Cough.
MAXIMUM STRENGTH
Mucus Relief
Severe Congestion and Cough
DEXTROMETHORPHAN HBr 20 mg COUGH SUPPRESSANT
GUAIFENESIN 400 mg • EXPECTORANT
PHENYLEPHRINE HCI 10 mg • NASAL DECONGESTANT
• Controls Cough• Relieves Nasal & Chest Congestion• Thins & Loosens Mucus
FOR AGES 12 +
9 FL OZ (266 mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
PEEL CORNER TO READ COMPLETE DRUG FACTS AND INFORMATION
‡Maximum Strength per 4 hour dose.
Manufactured by:
Raritan Pharmaceuticals
8 Joanna Court,
East Brunswick, NJ 08816
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® Fast-Max® Severe Congestion & Cough.
* Please review the disclaimer below.