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NDC 00031-8750-12 Robitussin Maximum Strength Severe Cough Plus Sore Throat 650; 20 mg/20mL; mg/20mL Details
Robitussin Maximum Strength Severe Cough Plus Sore Throat 650; 20 mg/20mL; mg/20mL
Robitussin Maximum Strength Severe Cough Plus Sore Throat is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 00031-8750-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 00031-8750-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
| NDC | 00031-8750 |
|---|---|
| Product ID | 0031-8750_90199483-457d-4f7b-915d-72250ec14390 |
| Associated GPIs | 43995502200925 |
| GCN Sequence Number | 080839 |
| GCN Sequence Number Description | acetaminophen/dextromethorphan LIQUID 325-10/10 ORAL |
| HIC3 | B4A |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-ANALGESIC COMBINATIONS |
| GCN | 47821 |
| HICL Sequence Number | 006331 |
| HICL Sequence Number Description | ACETAMINOPHEN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Robitussin Maximum Strength Severe Cough Plus Sore Throat |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | acetaminophen, dextromethorphan hydrobromide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 650; 20 |
| Active Ingredient Units | mg/20mL; mg/20mL |
| Substance Name | ACETAMINOPHEN; 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 | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00031-8750-12 (00031875012)
| NDC Package Code | 0031-8750-12 |
|---|---|
| Billing NDC | 00031875012 |
| Package | 1 BOTTLE in 1 CARTON (0031-8750-12) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2017-04-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |