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NDC 36800-0578-26 Topcare tussin dm 20; 200 mg/10mL; mg/10mL Details
Topcare tussin dm 20; 200 mg/10mL; mg/10mL
Topcare tussin dm is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates 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: 36800-0578-26Last Updated: 11/30/2022
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: 36800-0578-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 36800-0578 |
|---|---|
| Product ID | 36800-578_48ffeb53-c30e-4d1a-80b7-62329257dbc2 |
| Associated GPIs | 43997002520910 |
| 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 | Topcare tussin dm |
| Proprietary Name Suffix | sugar free cough and chest congestion |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 20; 200 |
| Active Ingredient Units | mg/10mL; mg/10mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Topco Associates 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 36800-0578-26 (36800057826)
| NDC Package Code | 36800-578-26 |
|---|---|
| Billing NDC | 36800057826 |
| Package | 1 BOTTLE in 1 CARTON (36800-578-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 1995-04-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c6817ac6-0591-4603-b198-ba979893eb1a 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
|
age |
dose |
|
adults and children 12 years and over |
10 mL every 4 hours |
|
children under 12 years |
do not use |
Other information
Inactive ingredients
Principal Display Panel
TopCare® health
COMPARE TO ROBITUSSIN® SUGAR-FREE COUGH + CHEST CONGESTION DM ACTIVE INGREDIENTS
PEAK COLD
NON-DROWSY
Tussin DM
Cough & Chest Congestion
COUGH SUPPRESSANT-DEXTROMETHORPHAN HBr
EXPECTORANT-GUIFENESIN
SUGAR-FREE
Specially Formulated For Diabetics
RELIEVES:
• Cough
• Mucus
Adult For Ages 12 & Over
4 FL OZ (118 mL)
CHERRY/MENTHOL FLAVOR
INGREDIENTS AND APPEARANCE
| TOPCARE TUSSIN DM
SUGAR FREE COUGH AND CHEST CONGESTION
dextromethorphan hbr, guaifenesin solution |
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| Labeler - Topco Associates LLC (006935977) |