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NDC 45802-0433-21 dextromethorphan polistirex extended release 30 mg/5mL Details
dextromethorphan polistirex extended release 30 mg/5mL
dextromethorphan polistirex extended release is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. 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: 45802-0433-21Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
| NDC | 45802-0433 |
|---|---|
| Product ID | 45802-433_d58d9232-d3e8-46fa-adac-a5ff81d79c7b |
| Associated GPIs | 4310203060G110 |
| GCN Sequence Number | 004630 |
| GCN Sequence Number Description | dextromethorphan polistirex SUS ER 12H 30 MG/5 ML ORAL |
| HIC3 | H6C |
| HIC3 Description | ANTITUSSIVES, NON-OPIOID |
| GCN | 17802 |
| HICL Sequence Number | 010295 |
| HICL Sequence Number Description | DEXTROMETHORPHAN POLISTIREX |
| Brand/Generic | Generic |
| Proprietary Name | dextromethorphan polistirex extended release |
| 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 | Padagis Israel Pharmaceuticals Ltd |
| 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 45802-0433-21 (45802043321)
| NDC Package Code | 45802-433-21 |
|---|---|
| Billing NDC | 45802043321 |
| Package | 1 BOTTLE in 1 CARTON (45802-433-21) / 89 mL in 1 BOTTLE |
| Marketing Start Date | 2012-09-10 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06416 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | DEXTROMETHORPHAN ER 30 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 7a6b68eb-8fe0-447d-aed7-28432c45b58c Details
Active ingredient (in each 5 mL)
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.
Allergy Alert: Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.
Ask a doctor before use if you have
- •
- chronic cough that lasts as occurs with smoking, asthma or emphysema
- •
- cough that occurs with too much phlegm (mucus)
Keep out of reach of children.
Directions
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- 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 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
D&C Red #30 aluminum lake, D&C Yellow #10 aluminum lake, flavor, 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
INGREDIENTS AND APPEARANCE
| DEXTROMETHORPHAN POLISTIREX EXTENDED RELEASE
dextromethorphan polistirex suspension |
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| Labeler - Padagis Israel Pharmaceuticals Ltd (600093611) |