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NDC 69676-0077-09 Cough and Chest Congestion Maximum Strength 20; 400 mg/5mL; mg/5mL Details
Cough and Chest Congestion Maximum Strength 20; 400 mg/5mL; mg/5mL
Cough and Chest Congestion Maximum Strength is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Genexa Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
Product Information
| NDC | 69676-0077 |
|---|---|
| Product ID | 69676-0077_e920b283-d6ba-fac8-e053-2995a90a3ee3 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Cough and Chest Congestion Maximum Strength |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 20; 400 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Genexa Inc. |
| 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 | 2023-12-31 |
Package
Package Images
NDC 69676-0077-09 (69676007709)
| NDC Package Code | 69676-0077-9 |
|---|---|
| Billing NDC | 69676007709 |
| Package | 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9) |
| Marketing Start Date | 2022-11-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e920b700-30d3-3266-e053-2a95a90a0639 Details
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
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)
SPL UNCLASSIFIED SECTION
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
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| COUGH AND CHEST CONGESTION MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin liquid |
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| Labeler - Genexa Inc. (079751024) |
Revised: 11/2022
Document Id: e920b283-d6ba-fac8-e053-2995a90a3ee3
Set id: e920b700-30d3-3266-e053-2a95a90a0639
Version: 1
Effective Time: 20221101