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| Product NDC Code | 58552-331 | ||||||
|---|---|---|---|---|---|---|---|
| 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 | TABLET | ||||||
| RxCUI drug identifier | 2167784 | ||||||
| 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.Drug Facts Active Ingredients (in each tablet) Dextromethorphan HBr, 28 mg Guaifenesin, 388 mg Phenylephrine HCl, 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 • Adults and Children 12 years and over: Take 1 tablet every 6 to 8 hours. Do not take more than 4 tablets in a 24 hour period. • Children 6 to 12 years of age: Take 1/2 tablet every 6 to 8 hours. Do not take more than 2 tablets in a 24-hour period. • Children under 6 years of age: Consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Croscarmellose Sodium, Dicalcium Phosphate, Hypromellose, Magnesium Silicate, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Mineral Oil, Polyvinylpyrrolidone, Silica, Sodium Lauryl Sulfate, Stearic Acid, Titanium Dioxide and Triacetin.
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 the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. Helps loosen phlegm (mucus), loosens nasal congestion, thin bronchial secretions, drain bronchial tubes, make coughs more productive, clear stuffy nose, clear nasal passageways, and shrinks swollen membranes.
Purpose
Information about the drug product’s indications for use.Purposes Antitussive Expectorant Nasal Decongestant
Spl product data elements
Usually a list of ingredients in a drug product.Giltuss Cough and Cold Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TALC CROSCARMELLOSE SODIUM CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN CELLULOSE, MICROCRYSTALLINE LIGHT MINERAL OIL POVIDONE K30 SILICON DIOXIDE SODIUM LAURYL SULFATE STEARIC ACID TITANIUM DIOXIDE TRIACETIN GUAIFENESIN GUAIFENESIN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE GILGIL;303303
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 20 TABLETS SUGAR FREE. DYE FREE. PRESERVATIVE FREE. RELIEVES COUGH AND COLD CHEST CONGESTION LOOSENS PHLEGM AND MUCUS STUFFY NOSE NASAL CONGESTION SINUS PRESSURE 58552-331 Cough Cold Tabs 10-11-2018
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.Other information Store at room temperature, USP Do not use if blister seal is broken
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 you have: heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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 more than the recommended dosage or if you are now 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional.
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 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 787-848-9114 , Mon.-Fri. 9:00 a.m. thru 5:00 p.m. 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 occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur These could 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 more than the recommended dosage or if you are now 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 are uncertain whether your prescription drug contains an MAOI, ask a health professional. Ask a doctor before use if you have: heart disease excessive phlegm (mucus) high blood pressure diabetes thyroid disease difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if: nervousness, dizziness, or sleeplessness occurs symptoms are accompanied by fever, rash, persistent headache, or excessive phlegm (mucus) cough and congestion do not improve within 7 days or tend to recur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of accidental overdose, get medical 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