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NDC 51660-0071-36 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 OHM LABORATORIES INC. 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: 51660-0071-36Last Updated: 11/30/2022
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: 51660-0071-36Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 51660-0071 |
|---|---|
| Product ID | 51660-071_e0cbdc72-78c1-4372-a09d-de74c383dbbf |
| 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 | OHM LABORATORIES INC |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021585 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 51660-0071-36 (51660007136)
| NDC Package Code | 51660-071-36 |
|---|---|
| Billing NDC | 51660007136 |
| Package | 2 BLISTER PACK in 1 CARTON (51660-071-36) / 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 400252ae-fe27-4f82-87f3-ead7eff335de Details
SPL UNCLASSIFIED SECTION
Uses
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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- temporarily relieves nasal congestion due to:
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- common cold
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- hay fever
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- upper respiratory allergies
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- temporarily restores freer breathing through the nose
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- promotes nasal and/or sinus drainage
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- 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
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- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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- cough accompanied by too much phlegm (mucus)
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 600 mg/60 mg Tablet Blister Pack Carton
INGREDIENTS AND APPEARANCE
| GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
guaifenesin and pseudoephedrine hydrochloride tablet, extended release |
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| Labeler - OHM LABORATORIES INC (184769029) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| RECKITT BENCKISER HEALTHCARE INTERNATIONAL LTD | 230780363 | MANUFACTURE(51660-071) | |