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NDC 53809-0240-01 DOMETUSS-NR 4; 20; 10 mg/1; mg/1; mg/1 Details
DOMETUSS-NR 4; 20; 10 mg/1; mg/1; mg/1
DOMETUSS-NR is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Domel Laboratories. The primary component is CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine 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: 53809-0240-01Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Chlorpheniramine
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: 53809-0240-01Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Dextromethorphan
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 53809-0240-01Last Updated: 02/05/2023
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 53809-0240 |
|---|---|
| Product ID | 53809-240_a0119974-f4dc-4a21-8934-6a4b74f578e3 |
| Associated GPIs | |
| GCN Sequence Number | 064259 |
| GCN Sequence Number Description | chlorpheniramine/phenyleph/DM TABLET 4-10-20 MG ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 99965 |
| HICL Sequence Number | 000375 |
| HICL Sequence Number Description | CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN |
| Brand/Generic | Generic |
| Proprietary Name | DOMETUSS-NR |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 4; 20; 10 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Domel Laboratories |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Rece |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53809-0240-01 (53809024001)
| NDC Package Code | 53809-240-01 |
|---|---|
| Billing NDC | 53809024001 |
| Package | 100 TABLET in 1 BOTTLE (53809-240-01) |
| Marketing Start Date | 2016-01-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |