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NDC 50383-0062-11 Dextromethorphan HBr and Guaifenesin 10; 100 mg/5mL; mg/5mL Details
Dextromethorphan HBr and Guaifenesin 10; 100 mg/5mL; mg/5mL
Dextromethorphan HBr and Guaifenesin is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Akorn. 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: 50383-0062-11Last 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: 50383-0062-11Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 50383-0062 |
|---|---|
| Product ID | 50383-062_c9b98014-38e5-4347-b26d-43c4c3aa7da1 |
| Associated GPIs | |
| GCN Sequence Number | 000652 |
| GCN Sequence Number Description | guaifenesin/dextromethorphan LIQUID 100-10MG/5 ORAL |
| HIC3 | B3T |
| HIC3 Description | NON-OPIOID ANTITUSSIVE AND EXPECTORANT COMBINATION |
| GCN | 53491 |
| HICL Sequence Number | 000223 |
| HICL Sequence Number Description | GUAIFENESIN/DEXTROMETHORPHAN HBR |
| Brand/Generic | Generic |
| Proprietary Name | Dextromethorphan HBr and Guaifenesin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Dextromethorphan HBr and Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Akorn |
| 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 | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 50383-0062-11 (50383006211)
| NDC Package Code | 50383-062-11 |
|---|---|
| Billing NDC | 50383006211 |
| Package | 4 TRAY in 1 CASE (50383-062-11) / 10 CUP, UNIT-DOSE in 1 TRAY (50383-062-10) / 10 mL in 1 CUP, UNIT-DOSE |
| Marketing Start Date | 2012-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ed74de02-852a-4dfe-8462-fa22044a2258 Details
Active ingredient
Inactive ingredients
Uses
Warnings
Do not use
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- •
- a cough that occur with too much phlegm (mucus)
- •
- a chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
- •
- a cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts
- These could be signs of a serious condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Professional note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5- hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).
Directions
- •
- take every 4 hours
- •
- do not exceed 6 doses in 24 hours
|
Age |
Dose |
|
Adults & children 12 years & over |
10 mL (2 teaspoonfuls) |
|
Children 6 years to under 12 years |
5 mL (1 teaspoonful) |
|
Children 2 years to under 6 years |
2.5 mL (1/2 teaspoonful) |
|
Children under 2 years |
Ask a doctor |
How Supplied: Dextromethorphan HBr and Guaifenesin Oral Solution is a clear viscous liquid with a slight cherry odor supplied in the following oral dosage forms: 5 mL unit dose, 10 mL unit dose in trays of 10 and 4 fl. oz. (118 mL) bottle
Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
Storage: Keep tightly closed. Store at controlled room temperature 20-25° C (68-77°F). [See USP] Protect from light.
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INGREDIENTS AND APPEARANCE
| DEXTROMETHORPHAN HBR AND GUAIFENESIN
dextromethorphan hbr and guaifenesin solution |
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| Labeler - Akorn (117696873) |
| Registrant - Akorn Operating Company LLC (117693100) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Akorn | 117696873 | MANUFACTURE(50383-062) , PACK(50383-062) | |