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| Product NDC Code | 58552-146 | ||||
|---|---|---|---|---|---|
| Drug Name | Childrens giltuss ex expectorant |
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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 | 310625 | ||||
| Application Number | M012 | ||||
| Labeler Name | Gil Pharmaceutical Corp | ||||
| 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 ingredients (in each 5 mL) Guaifenesin, 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 use enclosed dosing cup keep dosage cup for use with this product ml = milliliters children under 4 years Consult a doctor children 4 to under 6 years 2.5 mL every 4 hours children 6 to under 12 years 5 mL every 4 hours children 12 years and over 10 mL every 4 hours
| children under 4 years | Consult a doctor |
| children 4 to under 6 years | 2.5 mL every 4 hours |
| children 6 to under 12 years | 5 mL every 4 hours |
| children 12 years and over | 10 mL every 4 hours |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients citric acid, glycerin, methylparaben, natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.
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 and 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.Childrens Giltuss EX Expectorant Guaifenesin WATER GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED SUCRALOSE ANHYDROUS CITRIC ACID SODIUM CITRATE METHYLPARABEN PROPYLPARABEN 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.Children 4-12 Children's Giltuss® EX EXPECTORANT Alcohol Free, Sugar Free. Dye Free, Non Drowsy CHEST CONGESTION LIQUIFIES AND LOOSENS PHLEGM LIQUIFIES AND REMOVES MUCUS TUTTI FRUTTI FLAVOR 4FL OZ (118 mL) 58552-146 Expectorant Children
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.Drug Facts
Tamper Evident: do not use if safety seal is broken or missing. MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565 giltuss.com
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 your child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or chronic bronchitis
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.
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? Call 1-787-848-9114 , Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.
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 the child has a cough that lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 15°-30°C (59°-86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS
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 your child has cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with asthma or chronic bronchitis Stop use and ask a doctor if the child has a cough that lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition. 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