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NDC 00031-8718-13 Robitussin Maximum Strength Nighttime Cough DM 30; 12.5 mg/20mL; mg/20mL Details
Robitussin Maximum Strength Nighttime Cough DM 30; 12.5 mg/20mL; mg/20mL
Robitussin Maximum Strength Nighttime Cough DM is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE.
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: 00031-8718-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 00031-8718-13Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Doxylamine
Product Information
| NDC | 00031-8718 |
|---|---|
| Product ID | 0031-8718_2843123a-4fe6-4872-92fd-85077e45c9ee |
| Associated GPIs | 43995702200930 |
| GCN Sequence Number | 067481 |
| GCN Sequence Number Description | dextromethorphan hb/doxylamine LIQUID 7.5-3.125 ORAL |
| HIC3 | B4E |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-1ST GEN ANTIHISTAMINE COMB. |
| GCN | 30048 |
| HICL Sequence Number | 000392 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/DOXYLAMINE SUCCINATE |
| Brand/Generic | Generic |
| Proprietary Name | Robitussin Maximum Strength Nighttime Cough DM |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dextromethorphan hydrobromide, doxylamine succinate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 30; 12.5 |
| Active Ingredient Units | mg/20mL; mg/20mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE |
| Labeler Name | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Pharmaceutical Class | Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 00031-8718-13 (00031871813)
| NDC Package Code | 0031-8718-13 |
|---|---|
| Billing NDC | 00031871813 |
| Package | 1 BOTTLE in 1 CARTON (0031-8718-13) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2016-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |