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NDC 51660-0070-21 GUAIFENESIN 600 mg/1 Details
GUAIFENESIN 600 mg/1
GUAIFENESIN 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.
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: 51660-0070-21Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin
Product Information
| NDC | 51660-0070 |
|---|---|
| Product ID | 51660-070_66f1ce00-b45d-4ce2-8f38-c58eac2f795e |
| Associated GPIs | 43200010007420 |
| GCN Sequence Number | 071885 |
| GCN Sequence Number Description | guaifenesin TAB ER 12H 600 MG ORAL |
| HIC3 | B3J |
| HIC3 Description | EXPECTORANTS |
| GCN | 35905 |
| HICL Sequence Number | 000271 |
| HICL Sequence Number Description | GUAIFENESIN |
| Brand/Generic | Generic |
| Proprietary Name | GUAIFENESIN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Guaifenesin |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 600 |
| Active Ingredient Units | mg/1 |
| Substance Name | GUAIFENESIN |
| Labeler Name | OHM LABORATORIES INC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021282 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 51660-0070-21 (51660007021)
| NDC Package Code | 51660-070-21 |
|---|---|
| Billing NDC | 51660007021 |
| Package | 1 BLISTER PACK in 1 CARTON (51660-070-21) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2018-02-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 1cc8add2-55d9-4215-8f7b-07a2a9f45673 Details
Uses
Warnings
Ask a doctor before use if you have
- •
- 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
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- do not crush, chew, or break tablet
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- take with a full glass of water
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- this product can be administered without regard for the timing of meals
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- adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
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- children under 12 years of age: do not use
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton
INGREDIENTS AND APPEARANCE
| GUAIFENESIN
guaifenesin 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(51660-070) | |
Revised: 6/2019
Document Id: 66f1ce00-b45d-4ce2-8f38-c58eac2f795e
Set id: 1cc8add2-55d9-4215-8f7b-07a2a9f45673
Version: 5
Effective Time: 20190625