ACTINEL DM Pediatric

Manufacturer
ACTIPHARMA, LLC
Effective date
2026-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:44:01

Label at a glance#

ProductACTINEL DM Pediatric
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

• do not exceed 6 doses in any 24-hour period • mL = milliliter, tsp = teaspoon children 6 to under 12 years of age  10 mL (2 tsp) every 4 hours children 2 to under 6 years of age  5 mL (1 tsp) every 4 hours children under 2 years of age  consult a doctor

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 teaspoonful)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr 5 mg

Guaifenesin 75 mg

Phenylephrine HCl 2.5 mg

Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

• temporarily relieves:
  • nasal congestion due to the common cold
  • cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

Warnings

WARNINGS SECTION

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 accompanied by excessive phlegm (mucus) 
• persistent or chronic cough such occurs with asthma

When using this product
• do not exceed recommended dosage

Stop use and ask a doctor if
• your child gets nervous, dizzy, or sleepless 
• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• do not exceed 6 doses in any 24-hour period

• mL = milliliter, tsp = teaspoon

children 6 to under 12 years of age 10 mL (2 tsp) every 4 hours
children 2 to under 6 years of age 5 mL (1 tsp) every 4 hours
children under 2 years of age consult a doctor

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, flavor, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Questions or comments?

OTC - QUESTIONS SECTION

1.787.608.0882​

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

Call weekdays from 8AM to 4PM AST

SPL UNCLASSIFIED SECTION

Alcohol, Dye & Sugar FREE

Contains the same active ingredients as Tusnel​®​ DM Pediatric*

ActiPharma
COMMITTED TO HEALTH AND WELL-BEING
WWW.ACTIPHARMA.NET

Manufactured for Actipharma
San Juan, PR 00917.

Manufactured in USA with imported ingredients​

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTINEL​ DM PediatricACTINEL​ DM Pediatric

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1119541dextromethorphan HBr 5 MG / guaiFENesin 75 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN1
1119541dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD1
1119541dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG / phenylephrine hydrochloride 2.5 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
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-130-16ACTINEL DM Pediatric473 mL in 1 BOTTLE, PLASTICLIQUID4731

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63102-13063102-130-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
ACTINEL DM PediatricDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLCf85d8586-423f-48a3-9bb2-bbc5984c7cd32026-01-15WarningsExact identifier
ndc (package): 63102-130-16
ndc (product): 63102-130
ndc11 (package): 63102013016
spl id: e0485b3d-5021-4c2e-aa88-b10bcc2511a5
spl set id: f85d8586-423f-48a3-9bb2-bbc5984c7cd3

Reported adverse events (FAERS/openFDA)#

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