FDA Label for Severe Congestion And Cough
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH 20 ML)
- PURPOSE
- 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
Severe Congestion And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen 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
Purpose
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
- 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
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- diabetes
- 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 exceed recommended dosage.
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 persists more than 7 days, tends to recur, or is accompanied by a fever, 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 directed
- do not take more than 6 doses in any 24-hour period
- mL = milliliter
- only use the dose cup provided
- adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years: do not use
Other Information
- each 20 mL contains: sodium 9 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display Panel
NDC 0363-8004-45
Walgreens
WALGREENS PHARMACIST RECOMMENDED†
Compare to the active ingredients
in Mucinex® FAST-MAX®
Severe Congestion & Cough††
Severe
Congestion
& Cough
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
GUAIFENESIN / EXPECTORANT
PHENYLEPHRINE HCl / NASAL DECONGESTANT
Maximum Strength
• Controls cough
• Relieves nasal & chest congestion
• Thins & loosens mucus
• 12 years & older
6 FL OZ (177 mL)
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Learn about teen medicine abuse
www.StopMedicineAbuse.org
DISTRIBUTED BY:
WALGREEN CO.
DEERFIELD, IL 60015
100% SATISFACTION
GUARANTEED
walgreens.com
©2023 Walgreen Co.
†Our pharmacists recommend the Walgreens brand.
We invite you to compare to national brands.
††This product is not manufactured or distributed by RB Health (US)
LLC, owner of the registered trademark Mucinex® FAST-MAX®
Severe Congestion & Cough.
* Please review the disclaimer below.