Presgen Pediatric

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (75 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-03-24

Medication Information

Purpose

Cough Suppressant Expectorant Nasal Decongestant

Description

Dextromethorphan HBr, 5 mg Guaifenesin, 75 mg Phenylephrine HCl, 2.5 mg

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

Section 42229-5

Compare to Tussi-Pres^® Pediatric

Dextromethorphan HBr

COUGH SUPPRESSANTGuaifenesin

EXPECTORANTPhenylephrine HCl

NASAL DECONGESTANT

SUGAR AND ALCOHOL FREE

SACCHARIN AND SORBITOL FREE

DYE FREE

ORANGE FLAVOR

KramerNovis

Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis

San Juan, PR 00917

www.kramernovis.com

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

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.

Packaging

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

Drug Facts

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.

Active Ingredients

Dextromethorphan HBr, 5 mg

Guaifenesin, 75 mg

Phenylephrine HCl, 2.5 mg

Inactive Ingredients

citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions Or Comments?

Call weekdays from 8AM to 4 PM AST at 1.787.767.2072

Structured Label Content

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

Section 42229-5 (42229-5)

Compare to Tussi-Pres^® Pediatric

Dextromethorphan HBr

COUGH SUPPRESSANTGuaifenesin

EXPECTORANTPhenylephrine HCl

NASAL DECONGESTANT

SUGAR AND ALCOHOL FREE

SACCHARIN AND SORBITOL FREE

DYE FREE

ORANGE FLAVOR

KramerNovis

Pharmaceuticals within reach of patients

Manufactured in USA with imported ingredients for Kramer Novis

San Juan, PR 00917

www.kramernovis.com

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

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.

Packaging

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

Drug Facts

Other Information (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.

Active Ingredients (Active ingredients)

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.

Questions Or Comments? (Questions or comments?)

Call weekdays from 8AM to 4 PM AST at 1.787.767.2072

Advanced Ingredient Data

[{"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Compare to Tussi-Pres ® Pediatric Dextromethorphan HBr COUGH SUPPRESSANT Guaifenesin EXPECTORANT Phenylephrine HCl NASAL DECONGESTANT SUGAR AND ALCOHOL FREE SACCHARIN AND SORBITOL FREE DYE FREE ORANGE FLAVOR KramerNovis Pharmaceuticals within reach of patients Manufactured in USA with imported ingredients for Kramer Novis San Juan, PR 00917 www.kramernovis.com", "50565-1": "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.", "Purposes": "Cough Suppressant Expectorant Nasal Decongestant", "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.", "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", "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.", "Active ingredients": "Dextromethorphan HBr, 5 mg Guaifenesin, 75 mg Phenylephrine HCl, 2.5 mg", "Inactive ingredients": "citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.", "Questions or comments?": "Call weekdays from 8AM to 4 PM AST at 1.787.767.2072"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information