ACTISPEC PSE

Manufacturer
ACTIPHARMA, LLC
Effective date
2025-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:07:52

Label at a glance#

ProductACTISPEC PSE
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure11 sections

Indications and 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

Dosage and administration

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

Storage and handling

• 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.

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 10 mg

Guaifenesin 187 mg

Pseudoephedrine HCl 30 mg

Purpose

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

• 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTISPEC PSEACTISPEC PSE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1435143dextromethorphan HBr 10 MG / guaiFENesin 187 MG / pseudoephedrine HCl 30 MG in 5 mL Oral SolutionPSN1
1435143dextromethorphan hydrobromide 2 MG/ML / guaifenesin 37.4 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral SolutionSCD1
1435143dextromethorphan HBr 10 MG / guaifenesin 187 MG / pseudoephedrine HCl 30 MG per 5 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129
PSEUDOEPHEDRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-120-16ACTISPEC PSE473 mL in 1 BOTTLESOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63102-120-16ML - Milliliter63102-120bc48a8bf-9420-45cd-96fd-1c58c8b3d73412025-09-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63102-12063102-120-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACTISPEC PSEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC5def1555-87f4-41d5-8a5c-be560aa8f1e22025-07-17WarningsExact identifier
ndc (package): 63102-120-16
ndc (product): 63102-120
ndc11 (package): 63102012016
spl id: 109b340a-cf73-4886-87d5-edf2702f6a2c
spl set id: 5def1555-87f4-41d5-8a5c-be560aa8f1e2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.