Actispec® 

Actispec® 
SPL v1
SPL
SPL Set ID 5def1555-87f4-41d5-8a5c-be560aa8f1e2
Route
ORAL
Published
Effective Date 2025-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (187 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Citric Acid Monohydrate Methylparaben Ammonium Glycyrrhizate Potassium Citrate Propylene Glycol Propylparaben Water Sorbitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-17

Description

Dextromethorphan HBr 10 mg Guaifenesin 187 mg Pseudoephedrine HCl 30 mg

Purpose

Cough Suppressant Expectorant Nasal Decongestant


Medication Information

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Description

Dextromethorphan HBr 10 mg Guaifenesin 187 mg Pseudoephedrine HCl 30 mg

Uses

• temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm and thin bronchial secretions to make coughs more productive • temporarily relieves nasal congestion

Section 42229-5

Contains the same active ingredients as Trispec® PSE*

Alcohol FREE

Dye FREE

Sugar FREE

Grape Flavor

Manufactured in USA with imported ingredients for ActiPharma LLC. San Juan, PR 00917. www.actipharma.net. Rev. 04/25

* Trispec® PSE is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz 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.

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 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 • 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. These could be signs of a serious condition.

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

Packaging

Directions

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

 AGE  DOSE
Adults and children 12 years of age and over  Take 2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age  Take 1 teaspoonful (5 mL) every 4 hours
Children under 6 years of age  Ask physician

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, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Questions Or Comments?

call weekdays from 8 AM to 4PM AST at 1.787.608.0882.

Active Ingredients (in Each 5 Ml Tsp)

Dextromethorphan HBr 10 mg

Guaifenesin 187 mg

Pseudoephedrine HCl 30 mg


Structured Label Content

Uses

• temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm and thin bronchial secretions to make coughs more productive • temporarily relieves nasal congestion

Section 42229-5 (42229-5)

Contains the same active ingredients as Trispec® PSE*

Alcohol FREE

Dye FREE

Sugar FREE

Grape Flavor

Manufactured in USA with imported ingredients for ActiPharma LLC. San Juan, PR 00917. www.actipharma.net. Rev. 04/25

* Trispec® PSE is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz 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.

Purpose

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 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 • 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. These could be signs of a serious condition.

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

Packaging

Directions

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

 AGE  DOSE
Adults and children 12 years of age and over  Take 2 teaspoonfuls (10 mL) every 4 hours
Children 6 to under 12 years of age  Take 1 teaspoonful (5 mL) every 4 hours
Children under 6 years of age  Ask physician

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, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose

Questions Or Comments? (Questions or comments?)

call weekdays from 8 AM to 4PM AST at 1.787.608.0882.

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

Dextromethorphan HBr 10 mg

Guaifenesin 187 mg

Pseudoephedrine HCl 30 mg


Advanced Ingredient Data


Raw Label Data

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