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| Product NDC Code | 58552-130 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Giltuss cough and cold |
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| Type | Brand | ||||||
| Pharm Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | SOLUTION | ||||||
| RxCUI drug identifier | 1251031 | ||||||
| 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) Dextromethorphan HBr, 15 mg Guaifenesin, 300 mg Phenylephrine HCI, 10 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 exceed recommended dosage do not take more than 6 doses in any 24 hour period keep dosing cup for use with this product mL = milliliters adults and children 12 years & over 5 mL every 4 hours children 6 to under 12 years of age 2.5 mL every 4 hours children 2 to 6 years of age 1.25 mL every 4 hours children under 2 years of age Consult a doctor
| adults and children 12 years & over | 5 mL every 4 hours |
| children 6 to under 12 years of age | 2.5 mL every 4 hours |
| children 2 to 6 years of age | 1.25 mL every 4 hours |
| children under 2 years of age | Consult a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Citric acid, flavor, glycerin, hydroxyethylcellulose, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sorbitol solution, and 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 temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive temporarily relieves nasal congestion due to a cold
Purpose
Information about the drug product’s indications for use.Purposes Cough Suppressant Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Giltuss Cough and Cold Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride WATER POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL SUCRALOSE ANHYDROUS CITRIC ACID PROPYLPARABEN PROPYLENE GLYCOL METHYLPARABEN HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) GLYCERIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE
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.MAXIMUM STRENGTH GILTUSS ® COUGH & COLD ALCOHOL FREE. SUGAR FREE. DYE FREE RELIEVES COUGH AND COLD CHEST CONGESTION LOOSENS PHLEGM AND MUCUS STUFFY NOSE NASAL CONGESTION SINUS PRESSURE 4 FL OZ (118 mL) 58552-130
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
Other information store at room temperature 15°- 30°C (59° - 86°F) close cap tightlly SAVE CARTON FOR COMPLETE DRUG FACTS
Tamper evident: do not use if safety seal is broken or missing MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565
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 heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor a cough with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs).
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
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 accident overdose, get medical or professional help or contact a Poison Control Center immediately.
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 nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache These can be signs of a serious condition.
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 use if you are taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease, high blood pressure, thyroid disease, or diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor a cough with too much phlegm (mucus) a persistent or chronic cough such as occurs with smoking, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant, sedatives, tranquilizers, and drugs for depression, especially monoamine oxidase inhibitors (MAOIs). Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not get better within 7 days or are accompanied by fever cough lasts for more than 7 days, comes back, or occurs with fever, rash or persistant headache These can be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accident overdose, get medical or professional help or contact a Poison Control Center immediately.
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