Hbp Chest Congestion And Cough Relief Capsule, Liquid Filled
FDA Label NDC 0363-6681
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Hbp Chest Congestion And Cough Relief (NDC 0363-6681). 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) dextromethorphan hbr 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., 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 ifcough 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., 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 Hbr 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.
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 Ifcough 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.
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, Not More Than 12 Softgels In 24 Hours ■ Children Under 12 Years Of Age: Ask A Doctor
Other Information ■ Store Between 15° To 30°C (59° To 86°F) ■ Avoid Excessive Heat Above 40°C (104°F)
Inactive Ingredients Fd&C Red No.40, Gelatin, Glycerin, Polyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Sorbitan Solution, Titanium Dioxide
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