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

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.

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

Purpose

Antihistamine Cough suppressant Nasal decongestant

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.

Description

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

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

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

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

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.

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

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.

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

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

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