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NDC 00031-8765-16 Robitussin Maximum Strength 12 Hour Cough and Mucus Relief 60; 1200 mg/1; mg/1 Details
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief 60; 1200 mg/1; mg/1
Robitussin Maximum Strength 12 Hour Cough and Mucus Relief is a ORAL TABLET, 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; 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: 00031-8765-16Last 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: 00031-8765-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 00031-8765 |
|---|---|
| Product ID | 0031-8765_094ada80-3657-484d-e063-6294a90ac26c |
| 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 | Robitussin Maximum Strength 12 Hour Cough and Mucus Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan Hydrobromide, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 60; 1200 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) 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 | ANDA |
| Application Number | ANDA207602 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00031-8765-16 (00031876516)
| NDC Package Code | 0031-8765-16 |
|---|---|
| Billing NDC | 00031876516 |
| Package | 2 BLISTER PACK in 1 CARTON (0031-8765-16) / 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2019-06-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |