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NDC 63824-0535-66 Mucinex Fast-Max DM Max Honey and Berry Flavor 20; 400 mg/20mL; mg/20mL Details
Mucinex Fast-Max DM Max Honey and Berry Flavor 20; 400 mg/20mL; mg/20mL
Mucinex Fast-Max DM Max Honey and Berry Flavor is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
MedlinePlus Drug Summary
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 63824-0535-66Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 63824-0535-66Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
NDC | 63824-0535 |
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Product ID | 63824-535_fd4431ed-6ef9-4a83-b1df-02ba8afb774c |
Associated GPIs | 43997002520905 |
GCN Sequence Number | 023893 |
GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 100-5 MG/5 ORAL |
HIC3 | B3T |
HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
GCN | 53497 |
HICL Sequence Number | 000223 |
HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
Brand/Generic | Generic |
Proprietary Name | Mucinex Fast-Max DM Max Honey and Berry Flavor |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Dextromethorphan Hydrobromide and Guaifenesin |
Product Type | HUMAN OTC DRUG |
Dosage Form | SOLUTION |
Route | ORAL |
Active Ingredient Strength | 20; 400 |
Active Ingredient Units | mg/20mL; mg/20mL |
Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
Labeler Name | RB Health (US) LLC |
Pharmaceutical Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Ant |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 63824-0535-66 (63824053566)
NDC Package Code | 63824-535-66 |
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Billing NDC | 63824053566 |
Package | 180 mL in 1 BOTTLE (63824-535-66) |
Marketing Start Date | 2020-06-01 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.06234 |
Pricing Unit | ML |
Effective Date | 2023-12-20 |
NDC Description | MUCINEX FAST-MAX DM MAX LIQUID |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 2, 5, 6 |
Classification for Rate Setting | B |
As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL da1f1ef9-a974-4998-8e1d-c1d999596943 Details
SPL UNCLASSIFIED SECTION
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
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.
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- do not use dosing cup with other products
- dose as follows or as directed by a doctor
- adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours
- children under 12 years of age: do not use
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 180 mL Bottle Label
INGREDIENTS AND APPEARANCE
MUCINEX FAST-MAX DM MAX HONEY AND BERRY FLAVOR
dextromethorphan hydrobromide and guaifenesin solution |
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Labeler - RB Health (US) LLC (081049410) |