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| Product NDC Code | 58602-810 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 636522 | ||||||||||||||||
| Application Number | ANDA210453 | ||||||||||||||||
| Labeler Name | Aurohealth LLC | ||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each extended-release tablet) Guaifenesin USP 600 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 tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)
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 GUAIFENESIN GUAIFENESIN SILICON DIOXIDE HYPROMELLOSE 2208 (15000 MPA.S) HYPROMELLOSE 2910 (10000 MPA.S) MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE 101 MICROCRYSTALLINE CELLULOSE 102 POVIDONE K90 POVIDONE K25 STARCH, CORN white to off-white L;68
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.PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Label) AUROHEALTH NDC 58602-810-73 Guaifenesin Extended-Release Tablets 600 mg EXPECTORANT 12 HOUR Relieves Chest Congestion Thins And Loosens Mucus 20 Extended-Release Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Carton Label) AUROHEALTH NDC 58602-810-73 Compare to the active ingredient in Mucinex®* Guaifenesin Extended-release Tablets 600 mg EXPECTORANT •Relieves Chest Congestion •Thins And Loosens Mucus 12 HOUR 20 Extended Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg (20 Tablet Carton Label)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton (20 (1 x 20) Tablets) AUROHEALTH NDC 58602-810-96 Compare to the active ingredient in Mucinex®* Guaifenesin Extended-release Tablets 600 mg EXPECTORANT •Relieves Chest Congestion •Thins And Loosens Mucus 20 Extended-Release Tablets 12 HOUR PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg Blister Carton (20 (1 x 20) Tablets)
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? 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) You may also report side effects to this phone number. Distributed by: AUROHEALTH LLC. 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20° to 25°C (68° to 77°F)
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
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