Active Ingredients (In Each 20 Ml)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Mucus Relief Severe Congestion And Cough Solution
FDA Label NDC 76162-040
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Mucus Relief Severe Congestion And Cough (NDC 76162-040). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 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,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- difficulty in urination due to enlargement of the prostate gland
- heart disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- diabetes
- thyroid disease
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
- use by expiration date on package
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
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
+TopCare®
health
NDC 76162-040-45
COMPARE TO MUCINEX® FAST-MAX® SEVERE
CONGESTION & COUGH ACTIVE INGREDIENTS*
MAXIMUM STRENGTH
Mucus Relief
Severe Congestion
& Cough
DEXTROMETHORPHAN HBr
COUGH SUPPRESSANT
GUAIFENESIN • EXPECTORANT
PHENYLEPHRINE HCl • NASAL DECONGESTANT
MULTI-SYMPTOM RELIEF:
• Controls Cough
• Relieves Nasal &
Chest Congestion
• Thins & Loosens
Mucus
FOR AGES 12+
6 FL OZ (177 mL)
Mixed Berry
Flavored
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007
©TOPCO LNKA0223 QUESTIONS? 1-888-423-0139
[email protected] www.topcarebrand.com
Visit here or call 1-888-423-0139 for more information: http://topbrnds.com/4902b6
*This product is not manufactured or distributed by
RB Health (US) LLC, owner of the registered trademark
Mucinex® FAST-MAX® Severe Congestion & Cough.
50844 ORG042300445
Topcare 44-004 Org0423 (Topcare 44 004 1)
* Please review the disclaimer below.
