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| Product NDC Code | 58552-149 | ||||
|---|---|---|---|---|---|
| Drug Name | Giltuss diabetic dm |
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| Type | Brand | ||||
| Pharm Class | Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | SOLUTION | ||||
| RxCUI drug identifier | 1090496 | ||||
| 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 Ingredient (In each 10 mL) Purpose Dextromethorphan HBr. 30 mg ......................... Cough Suppresant Uses temporarily relieves: cough due to minor throat and bronchial irritation associated with a common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep
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 4 doses in any 24-hour period use enclosed dosing cup mL= milliliter Adults and children over 12 years 10 mL every 8 hours Children under 6 years to under 12 years 5 mL every 8 hours Children 4 years to under 6 years 2.5 mL use appropriate measuring syringe or measuring cup every 8 hours Children under 4 years Do not use
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acesulfame potassium, citric acid, flavor, glycerin, menthol, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sodium saccharin.
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.Ask a doctor before use if you have a cough with too much phlegm (mucus) a persistent or chronic cough 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 as these could be signs of a serious condition.
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.GILTUSS DIABETIC DM Dextromethorphan HBr POVIDONE PROPYLENE GLYCOL WATER SODIUM BENZOATE SACCHARIN SODIUM ACESULFAME POTASSIUM CITRIC ACID MONOHYDRATE GLYCERIN MENTHOL POLYETHYLENE GLYCOL, UNSPECIFIED DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN
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 Giltuss Diabetic DM - NDC 58552-149-04 - Bottle Label Giltuss Diabetic DM - NDC 58552-149-04 - Carton Label image description image description
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.MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information store at room temperature 15°-30°C (59°-86°F) close cap tightly SAVE CARTON FOR COMPLETE DRUG FACTS
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.
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 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 do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. When using this product do not use more than directed.
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