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| Product NDC Code | 0904-6763 | ||||
|---|---|---|---|---|---|
| Drug Name | Robafen |
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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 | SOLUTION | ||||
| RxCUI drug identifier | 213155, 310604 |
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| Application Number | M012 | ||||
| Labeler Name | Major Pharmaceuticals | ||||
| 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 ingredient (in each 10 mL) Guaifenesin, USP 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 • do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over 10 – 20 mL every 4 hours children under 12 years do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients anhydrous citric acid, caramel, FD&C red no. 40, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate
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.Use helps loosen phlegm (mucus) and thin bronchial secretions to 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.robafen Guaifenesin GUAIFENESIN GUAIFENESIN ANHYDROUS CITRIC ACID CARAMEL FD&C RED NO. 40 GLYCERIN HIGH FRUCTOSE CORN SYRUP PROPYLENE GLYCOL WATER SACCHARIN SODIUM SODIUM BENZOATE MENTHOL, UNSPECIFIED FORM dark
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 ROBAFEN ™ Congestion Formula Guaifenesin, USP 200 mg Expectorant Relieves: Mucus Chest Congestion Cherry Flavor Dosing Cup Included Alcohol Free For Adults Ages 12 and Over 4 FL OZ (118 mL) robafen image
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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 or comments? 1-800-616-2471
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 for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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 20-25 ° C (68-77 ° F). Do not refrigerate.
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 • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition. 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 (1-800-222-1222).
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