Otc - Active Ingredient
Active Ingredients (per 5 ml): Guaifenesin........75 mg
Phenylephrine HCl 2.5 mg
Dextromethorphan HBr 5 mg
Presgen Pediatric Syrup
FDA Label NDC 52083-653
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 Pediatric (NDC 52083-653). 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, warnings, dosage & administration, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose:Expectorant, Decongestant, Antitussive (Anti Cough)
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.
If you have:
heart disease
thyroid disease
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma,
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-20 ml(4 tsp) every 4 hours
Children 6 years to under 12 years-10ml (2 tsp) every 4 hours
Children 2 years to under 6 years-5ml (1 tsp) every 4 hours
under 2 years-Do not use
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, Glycerin,Methylparaben,Natural Flavor,Propylene Glycol,Propylparaben,Purified Water,Sodium Citrate and Sucralose
Package Label.Principal Display Panel
MM1
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
* Please review the disclaimer below.
