Otc - Active Ingredient
Drug Facts
Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Phenylephrine HCl 10 mg
Severe Congestion And Cough Max Solution
FDA Label NDC 63941-517
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Best Choice for the product Severe Congestion And Cough Max (NDC 63941-517). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Dextromethorphan HBr ..........Cough suppressant
Guaifenesin ...........................Expectorant
Phenylephrine HCl ................. Nasal Decongestant
Indications & Usage
Uses
■ helps loosen pjlegm (mucus)
and thin bronchial secretions
to drain bronchial tubes
■ Temporarily relieves these symptoms ocurring with a cold:
■ cough due to minor throat and bronchial irritation
■ nasal congestion
Warnings
Warnings
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.
■ for children under 12 years of age.
Ask a doctor before use if you have
■ heart disease
■ thyroid disease
■ high blood pressure
■ diabetes
■ trouble urinating due to an enlarged prostate gland
■ cough that lasts or is chronic
such as occurs with smoking, asthma,
chronic bronchitis or emphysema
■ cough that occurs with too much phlegm (mucus)
Otc - When Using
When using this product, do not use
more than directed
Otc - Stop Use
Stop use and ask a doctor if
■ nervousness, dizziness or sleeplessness occur
■ symptoms do not get better within 7 days or are accompanied by a fever
■ cough comes back, or occurs with fever, rash or persistent headache.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get
medical help or contact a Poison Control Center right
away.
Dosage & Administration
Directions
■ take only as recommended
■ use dosage cup
■ mL= milliliter
■ do not take more than 6 doses in any 24-hour period
| Adults & children 12 years and older | 20 mL every 4 hours |
| Children under 12 years of age | Do not use |
Other Safety Information
Other information
■ Each 20 mL contains: sodium 10 mg
■ dosage cup provided
■ store between 15-30° C (59-86° F)
■ do not refrigerate
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, edetate
disodium, FD&C Blue #1, FD&C Red
#40, flavors, glycerin, propylene
glycol, propyl gallate, purified water,
sodium benzoate, sorbitol, sucralose,
xanthan gum
Otc - Questions
Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
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Product Label: Best Choice® Max Severe Congestion & Cough
Best Choice®
MAXIMUM STRENGTH
Max Severe Congestion & Cough
6 FL OZ (177 mL)
PROUDLY DISTRIBUTED BY:
VALUE MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106
Compare to the active ingredients in
Mucinex® FAST-MAX™ Severe
Congestion & Cough*
*This product is not manufactured or
distributed by Reckitt Benckiser Inc.,
distributor of Mucinex® FAST-MAX™
Severe Congestion & Cough*
res
* Please review the disclaimer below.
