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NDC 57896-0736-04 Guaiasorb 10; 100 mg/5mL; mg/5mL Details
Guaiasorb 10; 100 mg/5mL; mg/5mL
Guaiasorb is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Geri-Care Pharmaceuticals, Corp. 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: 57896-0736-04Last 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: 57896-0736-04Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 57896-0736 |
|---|---|
| Product ID | 57896-736_63e3a228-2d0b-483a-ac93-13f58987826d |
| Associated GPIs | 43997002520910 |
| 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 | Guaiasorb |
| Proprietary Name Suffix | DM |
| Non-Proprietary Name | Dextromethorphan HBr, Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | Geri-Care Pharmaceuticals, Corp |
| 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
Package Images
NDC 57896-0736-04 (57896073604)
| NDC Package Code | 57896-736-04 |
|---|---|
| Billing NDC | 57896073604 |
| Package | 118 mL in 1 BOTTLE (57896-736-04) |
| Marketing Start Date | 2019-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6299e352-116e-43f2-b40f-c704a7bd5d61 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use if you are now taking prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 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 with too much phlegm (mucus)
- a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or headache that lasts. These could be signs of a serious condition
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| GUAIASORB
DM
dextromethorphan hbr, guaifenesin liquid |
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| Labeler - Geri-Care Pharmaceuticals, Corp (611196254) |