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NDC 71399-1006-04 Adult Tussin Cough and Chest Congestion DM Sugar Free 20; 200 mg/10mL; mg/10mL Details
Adult Tussin Cough and Chest Congestion DM Sugar Free 20; 200 mg/10mL; mg/10mL
Adult Tussin Cough and Chest Congestion DM Sugar Free is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Akron Pharma Inc.. 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: 71399-1006-04Last 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: 71399-1006-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 71399-1006 |
|---|---|
| Product ID | 71399-1006_98c8f525-56fd-4c53-be3b-e7ffd0e13d2c |
| Associated GPIs | |
| GCN Sequence Number | 000652 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53491 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Adult Tussin Cough and Chest Congestion DM Sugar Free |
| 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; 200 |
| Active Ingredient Units | mg/10mL; mg/10mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Akron Pharma 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 71399-1006-04 (71399100604)
| NDC Package Code | 71399-1006-4 |
|---|---|
| Billing NDC | 71399100604 |
| Package | 118 mL in 1 BOTTLE, PLASTIC (71399-1006-4) |
| Marketing Start Date | 2022-11-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1505298a-528f-4f94-b926-1e78d0b3f58e Details
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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- mL= milliliter
- this adult product is not intended for use in children under 12 years of age
- adults and children 12 years and over: 10 mL every 4 hours
- children under 12 years: do not use
Other information
Inactive ingredients
INGREDIENTS AND APPEARANCE
| ADULT TUSSIN COUGH AND CHEST CONGESTION DM SUGAR FREE
dextromethorphan hbr, guaifenesin liquid |
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| Labeler - Akron Pharma Inc. (067878881) |
| Registrant - SLV PHARMACEUTICALS LLC (081225162) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| SLV PHARMACEUTICALS LLC | 081225162 | manufacture(71399-1006) | |