Otc - Active Ingredient
Active Ingredients per 5 ml: Guaifenesin 200 mg, Phenylephrine HCL 5 mg, Dextromethorphan HBr 10 mg
Presgen Syrup
FDA Label NDC 52083-632
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Presgen (NDC 52083-632). 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, indications & usage, warnings, dosage & administration, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
COUGH SUPPRESSANT
NASAL DECONGESTANT
EXPECTORANT
Indications & Usage
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
temporarily relieves these symptoms occurring with cold:
nasal congestion
cough due to minor throat and bronchial irritation
Warnings
Do Not Use: in a child under 2 years of age
if you are 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 heart disease, thyroid disease, high blood pressure, diabetes
trouble urinating due to enlargement of the prostate gland
cough that occurs with too much phlegm (mucus)
chronic bronchitis or emphysema
When using this product, do not exceed recommended dosage
Stop use and ask a doctor if
you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days or are accompanied by fever
cough lasts more than 7 days, comes back, or is accompanied by fever,
rash, or persistent headache. These could be signs of a serious condition
Dosage & Administration
adults and children 12 years and over 10mL (2 tsp) every 4 hours
children 6 to under 12 years 5mL (1 tsp) every 4 hours
children 2 to under 6 years 2.5mL (1/2 tsp) every 4 hours
under 2 years do not use
do not take more than 6 doses in any 4 hour period
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
Inactive Ingredient
Inactive Ingredients:
citric acid,red 40,glycerin,methylparaben,potassium sorbate,propylene glycol,propylparaben,purified water,sodium citrate,sucralose
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