Otc - Active Ingredient
Dextromethorphan HBr 20mg
Guaifenesin 400mg
Dextromethorphan Hbr, Guaifenesin Capsule, Liquid Filled
FDA Label NDC 69729-781
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Dextromethorphan Hbr, Guaifenesin (NDC 69729-781). 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 otc - active ingredient, otc - purpose, inactive ingredient, dosage & administration, indications & usage, warnings, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Cough suppressant
Expectorant
Inactive Ingredient
FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide.
Dosage & Administration
Do not take more than directed – See overdose warning
Do not use for more than 7 days
Do not take more than 6 doses in 24 hours
Adults and children 12 years of age and 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
Indications & Usage
Helps loosen phlegm (mucus)
Helps 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.
- Cough that occurs with too much phlegm (mucus)
- Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor before use if you have:
Stop use and ask a doctor if:
Cough lasts for 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Overdosage
OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Other Safety Information
store at room temperature between 20-25°C (68-77°F)
avoid excessive heat and humidity
Package Label.Principal Display Panel
Pentrexcilina (Pentrexcilina)
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