Search by Drug Name or NDC
NDC 36800-0419-26 Topcare Mucus Relief 5; 100 mg/5mL; mg/5mL Details
Topcare Mucus Relief 5; 100 mg/5mL; mg/5mL
Topcare Mucus Relief 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: 36800-0419-26Last 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: 36800-0419-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 36800-0419 |
|---|---|
| Product ID | 36800-419_d4f7e3a8-e54a-49c5-a5bc-933216057cda |
| 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 | Topcare Mucus Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, 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 | Topco Associates 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 36800-0419-26 (36800041926)
| NDC Package Code | 36800-419-26 |
|---|---|
| Billing NDC | 36800041926 |
| Package | 1 BOTTLE in 1 CARTON (36800-419-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2007-11-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 701319ea-d0c4-423c-84aa-68568a12b4c1 Details
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 take more than 6 doses in any 24-hour period
- •
- measure only with dosing cup provided
- •
- do not use dosing cup with other products
- •
- mL = milliliter
|
Age |
Dose |
|
children 6 years to under 12 years |
5 mL - 10 mL every 4 hours |
|
children 4 years to under 6 years |
2.5 mL – 5 mL every 4 hours |
|
children under 4 years |
do not use |
Other information
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| TOPCARE MUCUS RELIEF
dextromethorphan hydrobromide, guaifenesin solution |
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
|
||||||||||||||||||||||||||
| Labeler - Topco Associates LLC (006935977) |