Active Ingredient (In Each Soft Gelatin Capsule)
Guaifenesin USP 400mg
Dextromethorphan HBr USP 20mg
Guaifenesin,dextromethorphan Hbr Capsule, Liquid Filled
FDA Label NDC 35916-0759
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 Pvt Ltd for the product Guaifenesin, Dextromethorphan Hbr (NDC 35916-0759). 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, when using this product, 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
Expectorant
Cough suppressant
Indications & Usage
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 rid the bronchial passageways of bothersome mucus and make coughs more productive
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
- cough accompained by excessive phlegm(mucus)
- persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema
When Using This Product
- do not exceed recommended dosage
- do not use for more than 7 days
Otc - Stop Use
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.
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 accidental overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- do not exceed 6 doses in 24 hours
- take with a full glass of water
- adults and children 12 years of age and over: take 1 softgel every 4 hours
- children under 12 years of age: do not use
Other Safety Information
Other information
- store at 25°C (77°F); excursions permitted between 15° -30°C (59° -86°F)
- Keep in dry place and do not expose to heat
Inactive Ingredient
Inactive ingredients
gelatin, glycerin, polyethylene glycol 400, povidone k-30,propylene glycol, purified water, sorbitol sorbitan solution
Package Label.Principal Display Panel
bulk label
* Please review the disclaimer below.
