Presgen

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Fd&c Red No. 40 Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-03-28

Medication Information

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Description

Dextromethorphan HBr, 10 mg Guaifenesin, 200 mg Phenylephrine HCl, 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^®

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

NASAL DECONGESTANT

Phenylephrine HCl

SUGAR AND ALCOHOL FREE

SACCHARIN FREE

SORBITOL FREE

CHERRY 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.

Warnings

Do not use • 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease • high blood pressure

• thyroid disease • diabetes

• trouble urinating due to 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.

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.

age	dose
Adults and Children 12 years of age and over	2 teaspoons (10 mL) every 4 hours
Children 6 to under 12 years of age	1 teaspoon (5 mL) every 4 hours
Children under 6 years of age	do not use

drug Facts

Inactive Ingredients

citric acid, FD&C Red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

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 or humidity.

Questions Or Comments?

Call weekdays from 8AM to 4PM AST at 1.787.767.2072

Active Ingredients (in Each 5 Ml, 1 Teaspoon)

Dextromethorphan HBr, 10 mg

Guaifenesin, 200 mg

Phenylephrine HCl, 5 mg

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^®

COUGH SUPPRESSANT

Dextromethorphan HBr

EXPECTORANT

Guaifenesin

NASAL DECONGESTANT

Phenylephrine HCl

SUGAR AND ALCOHOL FREE

SACCHARIN FREE

SORBITOL FREE

CHERRY 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.

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Do not use • 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• heart disease • high blood pressure

• thyroid disease • diabetes

• trouble urinating due to 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.

If pregnant or breast-feeding, ask a health professional before use.

Packaging

directions (Directions)

do not take more than 6 doses in any 24-hour period.

age	dose
Adults and Children 12 years of age and over	2 teaspoons (10 mL) every 4 hours
Children 6 to under 12 years of age	1 teaspoon (5 mL) every 4 hours
Children under 6 years of age	do not use

drug Facts (Drug Facts)

Inactive Ingredients (Inactive ingredients)

citric acid, FD&C Red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

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 or humidity.

Questions Or Comments? (Questions or comments?)

Call weekdays from 8AM to 4PM AST at 1.787.767.2072

Active Ingredients (in Each 5 Ml, 1 Teaspoon) (Active ingredients (in each 5 mL, 1 teaspoon))

Dextromethorphan HBr, 10 mg

Guaifenesin, 200 mg

Phenylephrine HCl, 5 mg

Advanced Ingredient Data

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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 ® COUGH SUPPRESSANT Dextromethorphan HBr EXPECTORANT Guaifenesin NASAL DECONGESTANT Phenylephrine HCl SUGAR AND ALCOHOL FREE SACCHARIN FREE SORBITOL FREE CHERRY 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.", "Purpose": "Cough Suppressant Expectorant Nasal Decongestant", "Warnings": "Do not use • 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 a MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to 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. If pregnant or breast-feeding, ask a health professional before use.", "Directions": "do not take more than 6 doses in any 24-hour period. age dose Adults and Children 12 years of age and over 2 teaspoons (10 mL) every 4 hours Children 6 to under 12 years of age 1 teaspoon (5 mL) every 4 hours Children under 6 years of age do not use", "Inactive ingredients": "citric acid, FD&C Red 40, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.", "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 or humidity.", "Questions or comments?": "Call weekdays from 8AM to 4PM AST at 1.787.767.2072", "Active ingredients (in each 5 mL, 1 teaspoon)": "Dextromethorphan HBr, 10 mg Guaifenesin, 200 mg Phenylephrine HCl, 5 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information