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Product NDC Code | 57896-794 | ||||||
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Drug Name | Mucus relief |
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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 | M012 | ||||||
Labeler Name | Geri-Care Pharmaceuticals, Corp | ||||||
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 full glass of water do not exceed recommended dose adults and children 12 years of age and over 1 tablet, every 4 hours, while symptoms persist • do not exceed 6 doses in 24 hours children under 12 years of age do not use
adults and children 12 years of age and over | 1 tablet, every 4 hours, while symptoms persist • do not exceed 6 doses 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 cellulose, magnesium stearate, maltodextrin, povidone, silica, sodium starch glycolate, 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 make coughs more productive to rid the bronchial passageways of bothersome mucus
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.MUCUS RELIEF Guaifenesin CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE MALTODEXTRIN POVIDONE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID GUAIFENESIN GUAIFENESIN TCL272
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 NDC 57896-794-01 GERICARE Mucus Relief Guaifenesin 400 mg expectorant relieves chest congestion thins and loosens mucus 100 tablets 400 mg each Mucus Relief label
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing. • store at controlled room temperature 20 °-25°C (68°-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 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 excessive phlegm (mucus) Stop use and ask a doctor if cough lasts more than 7 days or comes back cough occurs with fever, rash or persistent headache these could be signs of a serious illness. If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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