Drugplain

PRESGEN PEDIATRIC 5 mg/5mL

GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE · SYRUP · KRAMER NOVIS

No Recall History
Plain English

PRESGEN PEDIATRIC is a syrup containing guaifenesin, phenylephrine hcl,dextromethorphan hydrobromide at 5 mg/5mL, taken oral. Manufactured by KRAMER NOVIS.

Key Facts

Brand Name
PRESGEN PEDIATRIC
Generic Name
GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE
NDC Code (Product)
52083-653
Manufacturer
KRAMER NOVIS
Strength
5 mg/5mL
Dosage Form
SYRUP
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
03/24/2011

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes • temporarily relieves these symptoms occurring with a cold: • nasal congestion • cough due to minor throat and bronchial irritation

Dosage & Administration

Directions • do not take more than 6 doses in any 24-hour period. • mL = milliliter age dose Adults and Children 12 years of age and over 4 teaspoons (20 mL) every 4 hours Children 6 to under 12 years of age 2 teaspoons (10 mL) every 4 hours Children 2 to under 6 years of age 1 teaspoon (5 mL) every 4 hours Children under 2 years of age do not use

Warnings

Warnings Do not use • in a child under 2 years of age • in a child who is 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 child’s prescription drug contains a MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • 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 • your child gets nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, come back, 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. In case of accidental overdose, get medical help or contact a Poison Control Center right aw

Frequently Asked Questions

What is PRESGEN PEDIATRIC used for?

PRESGEN PEDIATRIC contains GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE. It is a syrup taken oral. Consult your doctor for specific uses.

Is PRESGEN PEDIATRIC a controlled substance?

PRESGEN PEDIATRIC is not classified as a controlled substance by the DEA.

What is the generic name for PRESGEN PEDIATRIC?

The generic name for PRESGEN PEDIATRIC is GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE. There are 1 other brand versions of GUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDE.

What is the NDC code for PRESGEN PEDIATRIC 5 mg/5mL?

The NDC (National Drug Code) for PRESGEN PEDIATRIC 5 mg/5mL is 52083-653, listed by KRAMER NOVIS.

Product NDC

52083-653

Package NDC

52083-653-16

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)