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| Product NDC Code | 69729-788 | ||||
|---|---|---|---|---|---|
| Drug Name | Tesalon tesaperlas severe cold max relief |
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| Type | Brand | ||||
| Pharm Class | 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] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | CAPSULE, LIQUID FILLED | ||||
| RxCUI drug identifier | 1661740 | ||||
| Application Number | M012 | ||||
| Labeler Name | OPMX LLC | ||||
| 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 Active Ingredients (in each softgel) Active Ingredients (in each softgel) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
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.Adults and children 12 years of age & over Take 1 softgel every 4 hours with a full glass of water while symptoms persist Children under 12 years of age Do not use
| Adults and children 12 years of age & over | Take 1 softgel every 4 hours with a full glass of water while symptoms persist |
| Children under 12 years of age | Do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: D&C yellow No. 10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol, sorbitan solution, titanium dioxide.
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) helps thin bronchial secretions to make coughs more productive
Directions: Do not take more than directed- See Overdose warning Do not use for more than 7 days. Do not take more than 6 softgels in 24 hours
Purpose
Information about the drug product’s indications for use.Active Ingredients (in each softgel) Active Ingredients (in each softgel) Purpose Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant
| Dextromethorphan HBr 20 mg | Cough suppressant |
| Guaifenesin 400 mg | Expectorant |
Spl product data elements
Usually a list of ingredients in a drug product.TESALON Tesaperlas Severe Cold Max Relief Dextromethorphan HBr, Guaifenesin SORBITOL SORBITAN GELATIN GLYCERIN POVIDONE POLYETHYLENE GLYCOL, UNSPECIFIED WATER D&C YELLOW NO. 10 TITANIUM DIOXIDE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN GUAIFENESIN GUAIFENESIN PROPYLENE GLYCOL 781
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.Tesalon® Tesaperlas Adults Expectorant & Cough Suppressant Expectorante & Supresor de la Tos Controls cough Controla la tos Thins & loosens mucus Adelgaza y expulsa las flemas SOFTGELS Dextromethorphan HBr 20 mg / Guaifenesin 400 mg 20 Softgels Box Read & keep package for complete product information TAMPER EVIDENT; DO NOT USE IS PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING Tesaol tesaperlas
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
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: cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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
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: (619) 600-5632 (Mon-Fri 9am-5pm EST)
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 more than 7 days, recurs, 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.
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store at room temperature between 20-25°C (68-77°F) Avoid excessive heat and humidity
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 Parkison´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: cough that occurs with too much phlegm (mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema Stop use and ask a doctor if: cough lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breast-feeding: ask a health professional before use. Keep out of reach of children Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Promt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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