Active Ingredient (In Each Soft Gelatin Capsule)
Dextromethorphan HBr USP 10mg
Guaifenesin USP 200mg
Dextromethorphan Hbr,guaifenesin Capsule, Liquid Filled
FDA Label NDC 35916-0760
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Softgel Healthcare Private Limited for the product Dextromethorphan Hbr, Guaifenesin (NDC 35916-0760). 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 active ingredient (in each soft gelatin capsule), otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purposes
Cough suppresent
Expectorant
Indications & Usage
Uses
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- the intensity of coughing
- the impulse to cough to help you get to sleep
Warnings
Warnings
Otc - Do Not Use
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis, or emphysema
- cough that occurs with too much phlegm(mucus)
Otc - When Using
When using this product do not use more than directed
Otc - Stop Use
Stop use and ask a doctor if
- cough lasts more than 7 days,comes back,or occur with fever, rash, or headache that lasts.
These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
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.
Dosage & Administration
Directions
- do not take more than 12 liquid gels in any 24-hour period
- adults and children 12 years of age and over: take 2 liquid gels every 4 hours
- children under 12 years of age: do not use
Other Safety Information
Other information
- store at 20-25°C (68-77°F)
- avoid excessive heat
Inactive Ingredient
Inactive ingredients
D&C yellow 10, FD&C blue 1, gelatin, glycerin, polyethylene glycol 400, povidone k-30, purified water, sorbitol sorbitan solution, titanium dioxide
* Please review the disclaimer below.
