Presgen®

Drug Facts

Composition & Product

Active Ingredients

Brompheniramine (4 mg) Dextromethorphan (20 mg) Phenylephrine (10 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Methylparaben Propylene Glycol Propylparaben Water Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-03-29

Medication Information

Purpose

Antihistamine Cough suppressant Nasal decongestant

Description

Brompheniramine Maleate 4 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg

Uses

• temporarily relieves:

• runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies

• temporarily controls cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

• temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose

Section 42229-5

Brompheniramine Maleate

ANTIHISTAMINE

Dextromethorphan HBr

COUGH SUPPRESSANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR AND ALCOHOL FREE

SACCHARINE FREE

DYE FREE

Compare to Tussi-Press^®B

GRAPE FLAVOR

Kramer Novis

Pharmaceuticals within reach of patients

Manufactured for Kramer Novis

San Juan, PR 00917

www.kramernovis.com

Manufactured in the USA with imported ingredients

Section 50565-1

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

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Warnings

Do not use if you are now 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.

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • chronic cough that lasts such as occurs with smoking, asthma, or emphysema.

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product • do not exceed recommended dosage

• excitability may occur, especially in children • drowsiness may occur; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.

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

Packaging

Drug Facts

directions

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

• mL = milliliter, tsp = teaspoon

adults and children 12 years of age and over	5 mL (1 tsp) every 4 hours
children 6 to under 12 years of age	2.5 mL (½ tsp) every 4 hours
children under 6 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 or humidity.

Inactive Ingredients

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

Questions Or Comments?

You may also report serious side effects to this phone number.

Call weekdays from 8 AM to 4 PM AST

Active Ingredients (in Each 5 Ml Teaspoonful)

Brompheniramine Maleate 4 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Structured Label Content

Uses

• temporarily relieves:

• runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies

• temporarily controls cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

• temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose

Section 42229-5 (42229-5)

Brompheniramine Maleate

ANTIHISTAMINE

Dextromethorphan HBr

COUGH SUPPRESSANT

Phenylephrine HCl

NASAL DECONGESTANT

SUGAR AND ALCOHOL FREE

SACCHARINE FREE

DYE FREE

Compare to Tussi-Press^®B

GRAPE FLAVOR

Kramer Novis

Pharmaceuticals within reach of patients

Manufactured for Kramer Novis

San Juan, PR 00917

www.kramernovis.com

Manufactured in the USA with imported ingredients

Section 50565-1 (50565-1)

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

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Warnings

Do not use if you are now 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.

Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • chronic cough that lasts such as occurs with smoking, asthma, or emphysema.

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product • do not exceed recommended dosage

• excitability may occur, especially in children • drowsiness may occur; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.

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

Packaging

Drug Facts

directions (Directions)

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

• mL = milliliter, tsp = teaspoon

adults and children 12 years of age and over	5 mL (1 tsp) every 4 hours
children 6 to under 12 years of age	2.5 mL (½ tsp) every 4 hours
children under 6 years of age	do not use

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.

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

You may also report serious side effects to this phone number.

Call weekdays from 8 AM to 4 PM AST

Active Ingredients (in Each 5 Ml Teaspoonful) (Active Ingredients (in each 5 mL teaspoonful))

Brompheniramine Maleate 4 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves: • runny nose • sneezing • itching of the nose or throat • itchy, watery eyes due to hay fever or other upper respiratory allergies • temporarily controls cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • temporarily relieves nasal congestion due to hay fever or other upper respiratory allergies • temporarily restores freer breathing through the nose", "42229-5": "Brompheniramine Maleate ANTIHISTAMINE Dextromethorphan HBr COUGH SUPPRESSANT Phenylephrine HCl NASAL DECONGESTANT SUGAR AND ALCOHOL FREE SACCHARINE FREE DYE FREE Compare to Tussi-Press ® B GRAPE FLAVOR Kramer Novis Pharmaceuticals within reach of patients Manufactured for Kramer Novis San Juan, PR 00917 www.kramernovis.com Manufactured in the USA with imported ingredients", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "Purposes": "Antihistamine Cough suppressant Nasal decongestant", "Warnings": "Do not use if you are now 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. Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • glaucoma • cough that occurs with too much phlegm (mucus) • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis • chronic cough that lasts such as occurs with smoking, asthma, or emphysema. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product • do not exceed recommended dosage • excitability may occur, especially in children • drowsiness may occur; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Use caution when driving a motor vehicle or operating machinery. Stop use and ask a doctor if • you get nervous, dizzy, or sleepless • new symptoms occur • symptoms do not get better within 7 days or are accompanied by fever • coughs lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions. 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, tsp = teaspoon adults and children 12 years of age and over 5 mL (1 tsp) every 4 hours children 6 to under 12 years of age 2.5 mL (½ tsp) every 4 hours children under 6 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 or humidity.", "Inactive ingredients": "citric acid, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sucralose.", "Questions or comments?": "You may also report serious side effects to this phone number. Call weekdays from 8 AM to 4 PM AST", "Active Ingredients (in each 5 mL teaspoonful)": "Brompheniramine Maleate 4 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information