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| Product NDC Code | 62207-839 | ||||
|---|---|---|---|---|---|
| Drug Name | Guaifenesin |
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| Type | Generic | ||||
| Pharm Class | Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | TABLET, EXTENDED RELEASE | ||||
| RxCUI drug identifier | 310621, 636522 |
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| Application Number | ANDA213420 | ||||
| Labeler Name | Granules India Ltd | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each extended-release tablet) Guaifenesin 600 mg (for 600 mg) Guaifenesin 1200 mg (for 1200 mg)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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 of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (For 600 mg) adults and children 12 years of age and over: 1 extended-release tablet every 12 hours. Do not exceed 2 extended-release tablets in 24 hours. (For 1200 mg) children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients carbomer homopolymer type B; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Purpose
Information about the drug product’s indications for use.purpose Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.GUAIFENESIN GUAIFENESIN CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) HYPROMELLOSE 2910 (5 MPA.S) SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE GUAIFENESIN GUAIFENESIN HYPROMELLOSE 2910 (10000 MPA.S) G;600 GUAIFENESIN GUAIFENESIN HYPROMELLOSE 2910 (10000 MPA.S) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) HYPROMELLOSE 2910 (5 MPA.S) SODIUM STARCH GLYCOLATE TYPE A POTATO MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE GUAIFENESIN GUAIFENESIN Elliptical G;1200
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton Label NDC 62207- 839 -72 Compare to the active ingredient of Mucinex ® Guaifenesin Extended-Release Tablets 600 mg Guaifenesin 600 mg - Expectorant RELIEVES CHEST CONGESTION 12HR FOR DAY • Relieves Chest Congestion OR NIGHT • Thins and Loosens Mucus • Immediate and Extended Release 90 (9 x 10) EXTENDED-RELEASE TABLETS guaifenesin-600mg-carton
PRINCIPAL DISPLAY PANEL - 1200 mg Blister Carton Label NDC 62207- 840 -71 Compare to the active ingre dient of Mucinex ® Guaifenesin Extended-Release Tablets 1200 mg Maximum strength Guaifenesin 12 00 mg - Expectorant RELIEVES CHEST CONGESTION 12HR FOR DAY • Relieves Chest Congestion OR NIGHT • Thins and Loosens Mucus • Immediate and Extended Release 70 (7 x 10) EXTENDED-RELEASE TABLETS guaifenesin-1200mg-carton
PRINCIPAL DISPLAY PANEL guaifenesin-label3-jpg 1200-mg-bulk-label
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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)
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use for children under 12 years of age
Other information Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing. store between 20-25°C (68-77°F)
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API