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| Product NDC Code | 35916-0461 | ||||
|---|---|---|---|---|---|
| Drug Name | Dextromethorphan hydrobromide |
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| Type | Generic | ||||
| 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 | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1090487 | ||||
| Application Number | M012 | ||||
| Labeler Name | Softgel Healthcare Pvt Ltd | ||||
| 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 soft gelatin capsule) Dextromethorphan HBr, USP 15 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 8 capsules in any 24-hour period this adult product is not intended for use in children under 12 years of age age dose adults and children 12 years and over take 2 capsules every 6 to 8 hours, as needed children under 12 years do not use
| age | dose |
| adults and children 12 years and over | take 2 capsules every 6 to 8 hours, as needed |
| children under 12 years | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD & C Red no. 40, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propyl gallate, propylene glycol, sorbital sorbitan solution, 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.Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.
Purpose
Information about the drug product’s indications for use.Purpose Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.Dextromethorphan Hydrobromide Dextromethorphan Hydrobromide GLYCERIN GELATIN, UNSPECIFIED PROPYL GALLATE WATER SORBITOL PROPYLENE GLYCOL POVIDONE K30 DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN POLYETHYLENE GLYCOL 400 FD&C RED NO. 40 Transparent
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 ADULT NDC 35916-0461-1 *Compared to the active ingredientsin Robitussin ® Long-Acting CoughGels ® Dextromethorphan Hydrobromide Capsules, 15mg (Cough Suppressant) 20 Softgels Liquid Filled Capsules Upto 8 hour relief Non-Drowsy Formula For Ages 12 & Over Dextromethorphan Hydrobromide Capsules 15mg
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.Do Not Use if foil is torn or missing.
Manufactured By Softgel Healthcare Pvt. Ltd., Survey No. 20/1, Vandalur-Kelambakkam Road, Pudupakkam Village, Kancheepuram District, Tamilnadu - 603 103, India. Mfg. Lic. No.:XXXXXXXXXXXX
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 a cough that occurs with too much phlegm (mucus) a cough that lasts or is chronic as occurs with smoking, asthma, 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 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.
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.
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 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F) protect from light
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 cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. 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
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