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| Product NDC Code | 58593-255 | ||||
|---|---|---|---|---|---|
| Drug Name | Cough out |
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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 | 310604, 1099024 |
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| Application Number | M012 | ||||
| Labeler Name | Efficient Laboratories Inc. | ||||
| 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 teaspoonful 5 mls) Purpose Guiafenesin 100 mg (USP)............................................Expectorant
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: Shake well immediately before use. Do not exceed 6 doses in any 24 hour period. Adults and Children 12 years and over - 10 ml (2 tsps) every 4 hours Children 6 to under 12 years of age - 5 ml (1 tsp) every 4 hours Children under 6 years of age - Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Vera, Aspartame, Honey, Menthol, Methylparaben, Potassium Sorbate, Propylene Glycol, Propylparaben, Purified 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.Purpose Expectorant
Spl product data elements
Usually a list of ingredients in a drug product.Cough Out Guaifenesin ALOE VERA LEAF HONEY MENTHOL POTASSIUM SORBATE PROPYLENE GLYCOL PROPYLPARABEN METHYLPARABEN WATER ASPARTAME GUAIFENESIN GUAIFENESIN
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.CoughOutLabel
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 accidental overdose, get medical help or contact the Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Each 5 mls contains: sodium 5 mg, and potassium 5 mg Phenylketonurics: Contains Phenylalanine 2.5 mg per 5 ml (teaspoonful).
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? 305.805.3456 Monday-Friday 9AM to 5PM EST www.efficientlabs.com
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.Warnings Do not exceed recommended dosage Ask a doctor before use if you have a cough that is accompanied by excessive phlegm (mucus) a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema. 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 persstent headached. 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