Cvs Health Chest Congestion And Cough Hbp Softgel Capsule, Liquid Filled
FDA Label NDC 51316-830
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy, Inc for the product Cvs Health Chest Congestion And Cough Hbp Softgel (NDC 51316-830). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each softgel), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each Softgel)
Dextromethorphan hydrobromide 10 mg
Guaifenesin 200 mg
Purpose
Cough suppressant
Expectorant
Uses
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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 • if you have ever had an allergic reaction to this product or any of its ingredients • in children under 12 years of age
Ask a doctor before use if you have
• cough that occurs with excessive phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury.
Directions
• do not exceed recommended dose
• adults and children 12 years and over: 1 or 2 softgels every 4 hours. Do not take more than 12 softgels in 24 hours or as directed by a doctor
• children under 12 years of age: do not use
Other Information
• store at room temperature between 20°-25°C (68°-77°F) • protect from freezing
• avoid excessive heat above 40°C (104°F) • protect from excessive moisture
Inactive Ingredients
FD&C Red No.40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide
Questions Or Comments?
Call 1-800-SHOP-CVS
Packaging
Cvs-830 (51316830 1)
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