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NDC 00031-8753-03 Robitussin 12 Hour Cough Relief 30 mg/5mL Details
Robitussin 12 Hour Cough Relief 30 mg/5mL
Robitussin 12 Hour Cough Relief is a ORAL SUSPENSION, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) 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: 00031-8753-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
| NDC | 00031-8753 |
|---|---|
| Product ID | 0031-8753_76e2e2e1-5df8-45fc-b9d2-3e2155ecac5a |
| 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 | Robitussin 12 Hour Cough Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextromethorphan polistirex |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 30 |
| Active Ingredient Units | mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) 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
NDC 00031-8753-03 (00031875303)
| NDC Package Code | 0031-8753-03 |
|---|---|
| Billing NDC | 00031875303 |
| Package | 1 BOTTLE in 1 CARTON (0031-8753-03) / 89 mL in 1 BOTTLE |
| Marketing Start Date | 2015-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |