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NDC 62011-0475-01 Guaifenesin and Pseudoephedrine Hydrochloride 600; 60 mg/1; mg/1 Details
Guaifenesin and Pseudoephedrine Hydrochloride 600; 60 mg/1; mg/1
Guaifenesin and Pseudoephedrine Hydrochloride is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by STRATEGIC SOURCING SERVICES LLC. The primary component is GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 62011-0475-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
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: 62011-0475-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 62011-0475 |
|---|---|
| Product ID | 62011-0475_07be87a3-54dc-4ddb-bd01-45444b4cf0ac |
| Associated GPIs | |
| 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 Pseudoephedrine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin and Pseudoephedrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 600; 60 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | STRATEGIC SOURCING SERVICES LLC |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212542 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62011-0475-01 (62011047501)
| NDC Package Code | 62011-0475-1 |
|---|---|
| Billing NDC | 62011047501 |
| Package | 1 BLISTER PACK in 1 CARTON (62011-0475-1) / 18 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 d139fd8d-66fd-4484-8e78-ed90c505d999 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 nasal congestion due to:
- common cold
- hay fever
- upper respiratory allergies
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- temporarily relieves sinus congestion and pressure
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 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by too much phlegm (mucus)
Directions
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for timing of meals
- adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
- children under 12 years of age: do not use
Other information
Inactive ingredients
Questions?
PRINCIPAL DISPLAY PANEL - 600 mg/60 mg Tablet Blister Pack Carton
NDC 62011-0475-1
Health Mart®
Compare to Mucinex®D active ingredients†
12 HOUR
Mucus Relief D
Guaifenesin 600 mg/
Pseudoephedrine HCl 60 mg
Extended-Release Tablets
Expectorant/Nasal Decongestant
Clears Nasal/Sinus Congestion
Thins And Loosens Mucus
Immediate And Extended Release
ACTUAL SIZE
18 Extended-Release Tablets
INGREDIENTS AND APPEARANCE
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
guaifenesin and pseudoephedrine hydrochloride tablet, extended release |
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| Labeler - STRATEGIC SOURCING SERVICES LLC (116956644) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 184769029 | MANUFACTURE(62011-0475) | |