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NDC 63824-0943-12 Mucinex Childrens 5; 100 mg/1; mg/1 Details
Mucinex Childrens 5; 100 mg/1; mg/1
Mucinex Childrens is a ORAL GRANULE 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: 63824-0943-12Last 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: 63824-0943-12Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 63824-0943 |
|---|---|
| Product ID | 63824-943_a3080d71-61a2-4814-a63e-3fe61121ab26 |
| Associated GPIs | |
| GCN Sequence Number | 063317 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan GRAN PACK 100MG-5MG ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 99068 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Brand |
| Proprietary Name | Mucinex Childrens |
| Proprietary Name Suffix | Cough and Chest Congestion Mini-Melts Orange Creme |
| Non-Proprietary Name | Dextromethorphan Hydrobromide and Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GRANULE |
| Route | ORAL |
| Active Ingredient Strength | 5; 100 |
| Active Ingredient Units | mg/1; mg/1 |
| 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 63824-0943-12 (63824094312)
| NDC Package Code | 63824-943-12 |
|---|---|
| Billing NDC | 63824094312 |
| Package | 12 PACKET in 1 CARTON (63824-943-12) / 1 GRANULE in 1 PACKET |
| Marketing Start Date | 2022-01-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 66543190-1d3d-4259-ae73-d366ecbf9e52 Details
SPL UNCLASSIFIED SECTION
Uses
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 that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Directions
- empty entire contents of packet onto tongue and swallow
- for best taste, do not chew granules
- do not give more than 6 doses in any 24-hour period
- dose as follows or as directed by a doctor
| Age | Dose |
|---|---|
| adults and Children 12 years of age and over | 2 to 4 packets every 4 hours |
| children 6 years to under 12 years of age | 1 to 2 packets every 4 hours |
| children 4 years to under 6 years of age | 1 packet every 4 hours |
| children under 4 years of age | do not use |
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 12 Packet Carton
INGREDIENTS AND APPEARANCE
| MUCINEX CHILDRENS
COUGH AND CHEST CONGESTION MINI-MELTS ORANGE CREME
dextromethorphan hydrobromide and guaifenesin granule |
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| Labeler - RB Health (US) LLC (081049410) |