Actinel®

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (5 mg) Guaifenesin (50 mg) Pseudoephedrine (15 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, 5 mg Guaifenesin, 50 mg Pseudoephedrine HCl, 15 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

Contains the same active ingredients as Tusnel^® Pediatric*

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® Pediatric 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.

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Do not use 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 an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

• heart disease • high blood pressure • thyroid disease • diabetes • cough that occurs with too much phlegm (mucus) • a persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if your child is 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 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, 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
Children 6 to under 12 years of age	Take 2 teaspoonfuls (10 mL) every 4-6 hours
Children 2 to under 6 years of age	Take 1 teaspoonfuls (5 mL) every 4-6 hours
Children under 2 years of age	Ask a doctor

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, 5 mg

Guaifenesin, 50 mg

Pseudoephedrine HCl, 15 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)

Contains the same active ingredients as Tusnel^® Pediatric*

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® Pediatric 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.

Purposes

Cough Suppressant

Expectorant

Nasal Decongestant

Warnings

Do not use 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 an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

• heart disease • high blood pressure • thyroid disease • diabetes • cough that occurs with too much phlegm (mucus) • a persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if your child is 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 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, 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
Children 6 to under 12 years of age	Take 2 teaspoonfuls (10 mL) every 4-6 hours
Children 2 to under 6 years of age	Take 1 teaspoonfuls (5 mL) every 4-6 hours
Children under 2 years of age	Ask a doctor

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, 5 mg

Guaifenesin, 50 mg

Pseudoephedrine HCl, 15 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": "Contains the same active ingredients as Tusnel ® Pediatric* 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® Pediatric 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.", "Purposes": "Cough Suppressant Expectorant Nasal Decongestant", "Warnings": "Do not use 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 an MAOI, ask a doctor or pharmacist before giving this product. Ask a doctor before use if your child has • heart disease • high blood pressure • thyroid disease • diabetes • cough that occurs with too much phlegm (mucus) • a persistent or chronic cough such as occurs with asthma Ask a doctor or pharmacist before use if your child is 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 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, 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 Children 6 to under 12 years of age Take 2 teaspoonfuls (10 mL) every 4-6 hours Children 2 to under 6 years of age Take 1 teaspoonfuls (5 mL) every 4-6 hours Children under 2 years of age Ask a doctor ", "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, 5 mg Guaifenesin, 50 mg Pseudoephedrine HCl, 15 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information