PRESGEN PEDIATRIC GUAIFENESIN PHENYLEPHRINE HCLDEXTROMETHORPHAN HYDROBROMIDE KRAMER NOVIS FDA Approved 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
FunFoxMeds box
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients ( in each 5 mL 1 teaspoon ) Dextromethorphan HBr 5 mg Guaifenesin 75 mg Phenylephrine HCl 2.5 mg
Inactive Ingredients
Inactive ingredients citric acid flavor glycerin methylparaben propylene glycol propylparaben purified water sodium citrate sucralose.
Strengths
5 ml 5 mg 75 mg 2.5 mg
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
Packaging

Packaging PRESGEN PEDIATRIC

Package Descriptions
  • Packaging PRESGEN PEDIATRIC

Overview

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

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 & Precautions
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 away.
Purpose

Purposes Cough Suppressant Expectorant Nasal Decongestant

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.

Storage & Handling

Other information • Tamper evident feature: Do not use if security seal is torn, broken or missing. • Store at controlled room temperature 15-30°C (59-86°F). • Avoid excessive heat and humidity.

Questions

Questions or comments? Call weekdays from 8AM to 4 PM AST at 1.787.767.2072


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