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NDC 42192-0607-16 Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide 2; 10; 30 mg/5mL; mg/5mL; mg/5mL Details
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide 2; 10; 30 mg/5mL; mg/5mL; mg/5mL
Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide is a ORAL SYRUP in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acella Pharmaceuticals, LLC. The primary component is BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine 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: 42192-0607-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Brompheniramine
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: 42192-0607-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 42192-0607-16Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 42192-0607 |
|---|---|
| Product ID | 42192-607_075d5bfb-bb2e-9971-e063-6294a90a2e5b |
| Associated GPIs | 43995803321210 |
| GCN Sequence Number | 000909 |
| GCN Sequence Number Description | brompheniramine/pseudoephed/DM SYRUP 2-30-10/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 96136 |
| HICL Sequence Number | 000389 |
| HICL Sequence Number Description | BROMPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCL/DEXTROMETHORPHAN |
| Brand/Generic | Generic |
| Proprietary Name | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 2; 10; 30 |
| Active Ingredient Units | mg/5mL; mg/5mL; mg/5mL |
| Substance Name | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Acella Pharmaceuticals, LLC |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203375 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42192-0607-16 (42192060716)
| NDC Package Code | 42192-607-16 |
|---|---|
| Billing NDC | 42192060716 |
| Package | 473 mL in 1 BOTTLE, PLASTIC (42192-607-16) |
| Marketing Start Date | 2016-09-21 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.09902 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | BROMPHEN-PSE-DM 2-30-10 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |