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NDC 49035-0077-28 Guaifenesin and Dextromethorphan Hydrobromide 60; 1200 mg/1; mg/1 Details
Guaifenesin and Dextromethorphan Hydrobromide 60; 1200 mg/1; mg/1
Guaifenesin and Dextromethorphan Hydrobromide is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by WALMART STORES, INC.. 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: 49035-0077-28Last 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: 49035-0077-28Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 49035-0077 |
|---|---|
| Product ID | 49035-077_8d0e52eb-79d4-4ebb-85e9-9dcbee9f0a3f |
| Associated GPIs | 43997002527475 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Guaifenesin and Dextromethorphan Hydrobromide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin and Dextromethorphan Hydrobromide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 60; 1200 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | WALMART STORES, INC. |
| 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 | NDA |
| Application Number | NDA021620 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 49035-0077-28 (49035007728)
| NDC Package Code | 49035-077-28 |
|---|---|
| Billing NDC | 49035007728 |
| Package | 2 BLISTER PACK in 1 CARTON (49035-077-28) / 14 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2017-12-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c063ac3d-edbb-42b6-83c7-17cdc54cc1a3 Details
SPL UNCLASSIFIED SECTION
Uses
- •
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- •
- temporarily relieves:
- •
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- •
- the intensity of coughing
- •
- the impulse to cough to help you get to sleep
Warnings
Do not use
- •
- for children under 12 years of age
- •
- 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 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
- •
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- •
- cough accompanied by too much phlegm (mucus)
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg Tablet Blister Pack Carton
NDC 49035-077-28
equate™
Compare to
Maximum
Strength
Mucinex® DM
Active
Ingredients*
Maximum Strength
Mucus DM
Guaifenesin 1200 mg
& Dextromethorphan HBr 60 mg
Extended-Release Tablets
Expectorant & Cough Suppressant
- Controls cough
- Thins and loosens mucus
- Immediate and extended-release
28
EXTENDED-
RELEASE
TABLETS
12
HOUR
Actual Size
INGREDIENTS AND APPEARANCE
| GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
guaifenesin and dextromethorphan hydrobromide tablet, extended release |
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| Labeler - WALMART STORES, INC. (051957769) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD | 230780363 | MANUFACTURE(49035-077) | |