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NDC 36800-0899-21 TopCare Cough DM 30 mg/5mL Details
TopCare Cough DM 30 mg/5mL
TopCare Cough DM is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE.
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: 36800-0899-21Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
| NDC | 36800-0899 |
|---|---|
| Product ID | 36800-899_dde54df7-f8ab-437d-bb92-9e274723893f |
| 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 | TopCare Cough DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan polistirex |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE |
| 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 | ANDA |
| Application Number | ANDA091135 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0899-21 (36800089921)
| NDC Package Code | 36800-899-21 |
|---|---|
| Billing NDC | 36800089921 |
| Package | 1 BOTTLE in 1 CARTON (36800-899-21) / 89 mL in 1 BOTTLE |
| Marketing Start Date | 2015-07-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 65a01786-974b-42ab-964e-4017e72c3095 Details
Active ingredient (in each 5 mL)
Uses
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.
Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
Ask a doctor before use if you have
Stop use and ask a doctor if
Keep out of reach of children.
Directions
- •
- shake bottle well before use
- •
- 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 |
10 mL every 12 hours, not to exceed 20 mL in 24 hours |
|
children 6 to under 12 years of age |
5 mL every 12 hours, not to exceed 10 mL in 24 hours |
|
children 4 to under 6 years of age |
2.5 mL every 12 hours, not to exceed 5 mL in 24 hours |
|
children under 4 years of age |
do not use |
Other information
Inactive ingredients
artificial grape flavor, D&C Red #30 aluminum lake, FD&C Blue #1 aluminum lake, glycerin, high fructose corn syrup, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propylparaben, purified water, sodium metabisulfite, sodium polystyrene sulfonate, sucrose, tartaric acid, tragacanth gum, triacetin, xanthan gum
Package/Label Principal Display Panel
COMPARE TO CHILDREN’S DELSYM® ACTIVE INGREDIENT
children’s Cough DM
DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE ORAL SUSPENSION COUGH SUPPRESSANT
Dosing Cup Included
OUR PHARMACISTS RECOMMEND
Contains Sodium Metabisulfite, a Sulfite That May Cause Allergic-Type Reactions
12 HOUR COUGH RELIEF
FOR CHILDREN & ADULTS Age 4+
GRAPE FLAVORED LIQUID
3 FL OZ (89 mL)
ALCOHOL-FREE
Day or Night
INGREDIENTS AND APPEARANCE
| TOPCARE COUGH DM
dextromethorphan polistirex suspension |
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| Labeler - Topco Associates LLC (006935977) |