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Product NDC Code | 84379-313 | ||||
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Drug Name | Revasol tussin |
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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 | LIQUID | ||||
RxCUI drug identifier | 1606850 | ||||
Application Number | M012 | ||||
Labeler Name | Rnv LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Guafenesin 200 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 Directions: do not exceed more than 6 doses in any 24-hour period shake well before use measure only with dosing cup provided keep dosing cup with product mL=mililiter TSP=teaspoonful this adult product is not intended for use in children Age Dose adults and children 12 years of age and over 10 mL (2 teaspoonful) every 4 hours children under 12 years of age do not use
Age | Dose |
adults and children 12 years of age and over | 10 mL (2 teaspoonful) every 4 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 citric acid, FD&C #40, flavors, glycerin, menthol, propylene glycol, sodium benzoate, sucralose, water.
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.
Purpose
Information about the drug product’s indications for use.Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Revasol Tussin Guaifenesin GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID FD&C RED NO. 40 GLYCERIN MENTHOL PROPYLENE GLYCOL SODIUM BENZOATE SUCRALOSE WATER
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.revasol
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 the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments: 305-821-4002 Monday - Friday (9 AM - 5 PM EST)
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.Warning Ask a doctor before use if you have • a persistent or chronic cough such as occurs wiht smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus) Stop use and ask a doctor if • cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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