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NDC 63824-0946-03 Mucinex Childrens 5; 100 mg/5mL; mg/5mL Details
Mucinex Childrens 5; 100 mg/5mL; mg/5mL
Mucinex Childrens 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: 63824-0946-03Last 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: 63824-0946-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 63824-0946 |
|---|---|
| Product ID | 63824-946_d12a44d5-0b5b-48ee-93c5-592c4e3112d2 |
| 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 Childrens |
| Proprietary Name Suffix | Cough |
| Non-Proprietary Name | Dextromethorphan Hydrobromide and Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63824-0946-03 (63824094603)
| NDC Package Code | 63824-946-03 |
|---|---|
| Billing NDC | 63824094603 |
| Package | 1 BOTTLE in 1 CARTON (63824-946-03) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2018-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.05942 |
| Pricing Unit | ML |
| Effective Date | 2023-12-20 |
| NDC Description | CHILDREN'S MUCINEX COUGH LIQ |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 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 b8132c81-5291-431a-ad3a-ec8a3eb21c19 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 your child get to sleep
Warnings
Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Ask a doctor before use if the child has
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with asthma
Directions
- do not give 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
| Age | Dose |
|---|---|
| children 6 years to under 12 years of age | 5 mL – 10 mL every 4 hours |
| children 4 years to under 6 years of age | 2.5 mL – 5 mL every 4 hours |
| children under 4 years of age | do not use |
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
INGREDIENTS AND APPEARANCE
| MUCINEX CHILDRENS
COUGH
dextromethorphan hydrobromide and guaifenesin solution |
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| Labeler - RB Health (US) LLC (081049410) |
Revised: 4/2021
Document Id: d12a44d5-0b5b-48ee-93c5-592c4e3112d2
Set id: b8132c81-5291-431a-ad3a-ec8a3eb21c19
Version: 3
Effective Time: 20210426