Actinel®

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (15 mg) Guaifenesin (200 mg) Pseudoephedrine (30 mg)

Inactive Ingredients

Citric Acid Monohydrate Methylparaben Potassium Citrate Propylene Glycol Propylparaben Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-09-24

Medication Information

Purpose

Cough Suppressant Expectorant Nasal Decongestant

Description

Dextromethorphan HBr, 15 mg Guaifenesin, 200 mg Pseudoephedrine HCl, 30 mg

Section 42229-5

NEW FORMULA

Contains the same active ingredients as Tusnel^®*

SUGAR FREE

DYE FREE

ALCOHOL FREE

SACCHARIN FREE

COMMITTED TO HEALTH AND WELL-BEING

WWW.ACTIPHARMA.NET

Manufactured in USA with imported ingredients for ActiPharma, Inc.

San Juan, PR 00917.

* Tusnel® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

Section 50565-1

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

uses

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps control the cough reflex that causes coughing • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis).

Purposes

Cough Suppressant

Expectorant

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 • trouble urinating due to an 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

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed.

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 4 doses in any 24-hour period.

AGE	DOSE
Adults and children 12 years of age and over	Take 2 teaspoonfuls (10 mL) every 6 hours
Children under 12 years of age	do not use

drug Facts

Other Information

• Tamper Evident Feature: Do not use if inner seal is torn, cut, or opened

• Store at controlled room temperature 15°- 30°C (59° - 86°F)

• Avoid excessive heat or humidity.

Inactive Ingredients

Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

Questions Or Comments?

call weekdays from 8AM to 4PM AST at 1.787.608.0882

Active Ingredients (in Each 5 Ml Tsp)

Dextromethorphan HBr, 15 mg

Guaifenesin, 200 mg

Pseudoephedrine HCl, 30 mg

Structured Label Content

Section 42229-5 (42229-5)

NEW FORMULA

Contains the same active ingredients as Tusnel^®*

SUGAR FREE

DYE FREE

ALCOHOL FREE

SACCHARIN FREE

COMMITTED TO HEALTH AND WELL-BEING

WWW.ACTIPHARMA.NET

Manufactured in USA with imported ingredients for ActiPharma, Inc.

San Juan, PR 00917.

* Tusnel® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.

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.

uses (Uses)

• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps control the cough reflex that causes coughing • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis).

Purposes

Cough Suppressant

Expectorant

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 • trouble urinating due to an 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

Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant.

When using this product do not use more than directed.

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 4 doses in any 24-hour period.

AGE	DOSE
Adults and children 12 years of age and over	Take 2 teaspoonfuls (10 mL) every 6 hours
Children under 12 years of age	do not use

drug Facts (Drug Facts)

Other Information (Other information)

• Tamper Evident Feature: Do not use if inner seal is torn, cut, or opened

• Store at controlled room temperature 15°- 30°C (59° - 86°F)

• Avoid excessive heat or humidity.

Inactive Ingredients (Inactive ingredients)

Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

Questions Or Comments? (Questions or comments?)

call weekdays from 8AM to 4PM AST at 1.787.608.0882

Active Ingredients (in Each 5 Ml Tsp) (Active Ingredients (in each 5 mL tsp))

Dextromethorphan HBr, 15 mg

Guaifenesin, 200 mg

Pseudoephedrine HCl, 30 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"42229-5": "NEW FORMULA Contains the same active ingredients as Tusne l ®* SUGAR FREE DYE FREE ALCOHOL FREE SACCHARIN FREE COMMITTED TO HEALTH AND WELL-BEING WWW.ACTIPHARMA.NET Manufactured in USA with imported ingredients for ActiPharma, Inc. San Juan, PR 00917. * Tusnel® is a registered trademark of Llorens Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Llorens Pharmaceutical Corp.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. ", "Uses": "• temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold • helps control the cough reflex that causes coughing • helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies (allergic rhinitis).", "Purposes": "Cough Suppressant Expectorant 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 • trouble urinating due to an 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 Ask a doctor or pharmacist before use if you are taking any other oral nasal decongestant or stimulant. When using this product do not use more than directed. 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 4 doses in any 24-hour period. AGE DOSE Adults and children 12 years of age and over Take 2 teaspoonfuls (10 mL) every 6 hours Children under 12 years of age do not use", "Other information": "• Tamper Evident Feature: Do not use if inner seal is torn, cut, or opened • Store at controlled room temperature 15°- 30°C (59° - 86°F) • Avoid excessive heat or humidity.", "Inactive ingredients": "Citric Acid, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose", "Questions or comments?": "call weekdays from 8AM to 4PM AST at 1.787.608.0882", "Active Ingredients (in each 5 mL tsp)": "Dextromethorphan HBr, 15 mg Guaifenesin, 200 mg Pseudoephedrine HCl, 30 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information