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NDC 63824-0939-66 Mucinex FreeFrom Severe Congestion and Cough 20; 400; 10 mg/20mL; mg/20mL; mg/20mL Details
Mucinex FreeFrom Severe Congestion and Cough 20; 400; 10 mg/20mL; mg/20mL; mg/20mL
Mucinex FreeFrom Severe Congestion and Cough 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; PHENYLEPHRINE HYDROCHLORIDE.
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: 63824-0939-66Last 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: 63824-0939-66Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 63824-0939-66Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63824-0939 |
|---|---|
| Product ID | 63824-939_e102ab7f-6551-456f-af04-f01f66d8dd92 |
| Associated GPIs | 43997303100960 |
| GCN Sequence Number | 066559 |
| GCN Sequence Number Description | guaifen/dextromethorphan/PE LIQUID 5-2.5 MG/5 ORAL |
| HIC3 | B4R |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-EXPECTORANT |
| GCN | 28875 |
| HICL Sequence Number | 000216 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR/PHENYLEPHRINE |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex FreeFrom Severe Congestion and Cough |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 20; 400; 10 |
| Active Ingredient Units | mg/20mL; mg/20mL; mg/20mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], 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 |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63824-0939-66 (63824093966)
| NDC Package Code | 63824-939-66 |
|---|---|
| Billing NDC | 63824093966 |
| Package | 180 mL in 1 BOTTLE (63824-939-66) |
| Marketing Start Date | 2020-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06033 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | MUCINEX FREEFROM SEV CONG-COUG |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5, 6 |
| Classification for Rate Setting | B |
| As of Date | 2024-02-21 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL fecd2c6e-fba9-4b46-ab13-33a157294168 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
- nasal congestion due to a cold
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- 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 FREEFROM SEVERE CONGESTION AND COUGH
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride solution |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 1/2022
Document Id: e102ab7f-6551-456f-af04-f01f66d8dd92
Set id: fecd2c6e-fba9-4b46-ab13-33a157294168
Version: 3
Effective Time: 20220110