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Product NDC Code | 73057-379 | ||||
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Drug Name | Pharbinex |
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Type | Brand | ||||
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 | ||||
RxCUI drug identifier | 359601 | ||||
Application Number | part341 | ||||
Labeler Name | Ulai Health LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Guaifenesin 400 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 take with a full glass of water this product can be administered without regard for the timing of the meals do not exceed 6 doses in 24 hours or as directed by a doctor adults and children 12 years of age and over take 1 tablet every 4 hours as needed children 6 to under 12 years of age take ½ tablet every 4 hours as needed children under 6 years of age ask a doctor
adults and children 12 years of age and over | take 1 tablet every 4 hours as needed |
children 6 to under 12 years of age | take ½ tablet every 4 hours as needed |
children under 6 years of age | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide, stearic acid
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 helps make cough 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.Pharbinex Guaifenesin 400mg MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE POVIDONE K30 POVIDONE K90 SILICON DIOXIDE STEARIC ACID GUAIFENESIN GUAIFENESIN PH063
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.PHARBEST NDC 73057-379-04 Manufactured in the USA Immediate Release PHARBINEX *Compare to the active ingredient in Mucinex ® Tablets Guaifenesin 400mg Expectorant 30 TABLETS ULAI PHARBINEX 30CT. LABEL
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of registered trademark Mucinex ® Distributed by: ULAI HEALTH LLC. Alexandria, VA 22312
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? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)
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 sings 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 at 20 0 - 25 0 C (68 0 -77 0 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