ACTISPEC PSE- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride solution

ACTISPEC PSE by

Drug Labeling and Warnings

ACTISPEC PSE by is a Otc medication manufactured, distributed, or labeled by ACTIPHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 5 mL tsp)

Dextromethorphan HBr 10 mg

Guaifenesin 187 mg

Pseudoephedrine HCl 30 mg

Purpose

Cough Suppressant
Expectorant
Nasal Decongestant

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

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.

KEEP OUT OF REACH OF CHILDREN

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

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

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.

SPL UNCLASSIFIED SECTION

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.

Packaging

INGREDIENTS AND APPEARANCE

ACTISPEC PSE 
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63102-120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	187 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	grape	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63102-120-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/17/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/17/2025

Labeler - ACTIPHARMA, LLC (079340948)