Actinel®

Actinel®
SPL v2
SPL
SPL Set ID 16660d82-524b-42ca-8581-48237caa13b2
Route
ORAL
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (20 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Citric Acid Monohydrate Glycerin Menthol, Unspecified Form Methylparaben Polyethylene Glycol 400 Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-20

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

Purpose

Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Cough suppressant Expectorant Nasal decongestant

Description

Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 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® DM*

• Alcohol FREE • Dye FREE

• Sugar FREE • Great Flavor

Manufactured in USA with imported ingredients for ActiPharma. San Juan, PR 00917.  www.actipharma.net.

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

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 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 • difficulty in urination due to enlargement of the prostate gland • cough accompanied by excessive phlegm (mucus) • persistent or chronic cough 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 produ ct do not exceed recommended dosage.

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache. A persistent cough may be a sign of a serious condition.

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

Packaging

Directions
  • take every 4 hours, or as directed by a doctor. 
AGE DOSE
 adults and children 12 years

of age and over

 take 5mL (1tsp). Do not

exceed 6 doses in 24 hours

Children under 12 years of age   ask a doctor

Drug Facts

Other Information

• tamper evident feature: Do not use if safety seal is torn, broken or missing.

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

• avoid excessive heat or humidity. 

Inactive Ingredients

artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions Or Comments?

+1-787-608-0882

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

call weekdays from 8AM to 4PM AST

Active Ingredients (in Each 5 Ml Tsp)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 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® DM*

• Alcohol FREE • Dye FREE

• Sugar FREE • Great Flavor

Manufactured in USA with imported ingredients for ActiPharma. San Juan, PR 00917.  www.actipharma.net.

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

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 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 • difficulty in urination due to enlargement of the prostate gland • cough accompanied by excessive phlegm (mucus) • persistent or chronic cough 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 produ ct do not exceed recommended dosage.

Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occur • symptoms do not improve within 7 days or are accompanied by fever • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash or a persistent headache. A persistent cough may be a sign of a serious condition.

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

Packaging

Directions
  • take every 4 hours, or as directed by a doctor. 
AGE DOSE
 adults and children 12 years

of age and over

 take 5mL (1tsp). Do not

exceed 6 doses in 24 hours

Children under 12 years of age   ask a doctor

Drug Facts

Other Information (Other information)

• tamper evident feature: Do not use if safety 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)

artificial and natural flavors, citric acid, glycerin, menthol, methylparaben, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions Or Comments? (Questions or comments?)

+1-787-608-0882

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

call weekdays from 8AM to 4PM AST

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

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)