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| Product NDC Code | 72854-267 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Mucinex instasoothe cough |
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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 | LOZENGE | ||||||
| RxCUI drug identifier | 1370219 | ||||||
| Application Number | M012 | ||||||
| Labeler Name | RB Health (US) 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 Ingredient (in each Lozenge) Purpose Dextromethorphan HBr 5.0 mg Cough suppressant
| Dextromethorphan HBr 5.0 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 Label
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactives FD&C blue no. 1, FD&C red no. 40, flavors, hydrogenated starch hydrolysate, isomalt, propylene glycol, purified water, 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 reduce the intensity of coughing
Purpose
Information about the drug product’s indications for use.Purpose: Dextromethorphan HBr 5 mg: Cough suppressant
Spl product data elements
Usually a list of ingredients in a drug product.MUCINEX INSTASOOTHE COUGH DEXTROMETHORPHAN HYDROBROMIDE FD&C RED NO. 40 ISOMALT PROPYLENE GLYCOL FD&C BLUE NO. 1 WATER SUCRALOSE DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN HYDROGENATED STARCH HYDROLYSATE S
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.NDC 72854-267-20 Mucinex® INSTASOOTHE™ COUGH RELIEF Dextromethorphan HBr 5.0 mg | Cough Suppressant 3 IN 1 FORMULA ✔ Quiets Cough ✔ Lasts up to 4 hours ✔ Sugar Free See back panel for actual size 20 MEDICATED DROPS Label Label
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
Dist. by: RB Health (US) Parsippany, NJ 07054-0224 Made in India 2024 RB Health Patents: www/reckitt.com/patents www.mucinex.com
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 Infomation store at 20-25°C (68-77°F) protect contents from humidity keep lozenge in outer pack until use. Reseal outer pack after use.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions 1-866-MUCINEX (1-866-682-4639)
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. ■ in children under 6 years of age Ask a doctor before use if: ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Stop use and ask a doctor if: cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition. If pregnant or breastfeeding: ask a health professional before use.
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