Otc - Active Ingredient
Drug Facts
Active ingredients
(in each 20 mL)
Dextromethorphan HBr 20 mg
Guaifenesin 400 mg
Dm Max Solution
FDA Label NDC 63941-518
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 Dm Max (NDC 63941-518). 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
Indications & Usage
Uses
■ helps loosen phlegm (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
Warnings
Warnings
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
■ 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
■ cough lasts for more than 7 days
days 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.
In case of overdose, gel medical help or contact a
Poison Control Genter rightaway.
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 12 mg
■ dosage cup provided
■ store between 15-30° C (59-86° F)
■ do not refrigerate
Inactive Ingredient
Inactive ingredients
anhydrous citric acid, dextrose
D&C Blue #33, FD&C Red#40,
flavors, glycerin, maltitol,
propylene glycol, purified
water, saccharin sodium,
sodium benzoate, 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® DM Max
Best Choice®
MAXIMUM STRENGTH
DM Max
6 FL OZ (177 mL)
PROUDLY DISTRIBUTED BY:
VALUE MERCHANDISERS, CO.
5000 KANSAS AVE
KANSAS CITY, KS 66106
• This product is not manufactured or distributed by Reckitt Benckiser Inc.,
distributor of Mucinex" FAST-MAX™ DM MAX®
res
* Please review the disclaimer below.
