FDA.reportPublic FDA data

ACTINEL PEDIATRIC

Manufacturer
ACTIPHARMA, LLC
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:06:56

Label at a glance#

ProductACTINEL PEDIATRIC
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections

Indications and 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 

Dosage and administration

• do not take more than 4 doses in any 24-hour period. AGE DOSE  Children 6 to under 12 years  of age Take 2 teaspoonfuls (10 mL) every 4-6 hours Children 2 to under 6 years of age  Take 1 teaspoonfuls (5 mL) every 4-6 hours   Children under 2 years of age Ask 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 tsp)

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr, 5 mg
Guaifenesin, 50 mg
Pseudoephedrine HCl, 15 mg

Purposes

OTC - PURPOSE SECTION

Cough Suppressant
Expectorant
Nasal Decongestant

Uses

INDICATIONS & USAGE SECTION

• 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 

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 that occurs with too much phlegm (mucus) • a persistent or chronic cough such as occurs with asthma

Ask a doctor or pharmacist before use if your child is 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 child
• gets nervous, dizzy, or sleepless • symptoms do not get better within 7 days or are accompanied by fever • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or 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 take more than 4 doses in any 24-hour period.

AGEDOSE 
Children 6 to under 12 years 
of age		Take 2 teaspoonfuls
(10 mL) every 4-6 hours
Children 2 to under 6 years of
age 		Take 1 teaspoonfuls
(5 mL) every 4-6 hours 
 Children under 2 years of ageAsk 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, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

Questions or comments?

OTC - QUESTIONS SECTION

call weekdays from 8AM to 4PM AST at 1.787.608.0882

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Tusnel® Pediatric*

SUGAR FREE
DYE FREE
ALCOHOL FREE
SACCHARIN FREE

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

Manufactured in USA with imported ingredients for ActiPharma, Inc.
San Juan, PR 00917.

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pediatric-102Pediatric-102

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098911dextromethorphan HBr 5 MG / guaiFENesin 50 MG / pseudoephedrine HCl 15 MG in 5 mL Oral SolutionPSN6
1098911dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / pseudoephedrine hydrochloride 3 MG/ML Oral SolutionSCD6
1098911dextromethorphan HBr 5 MG / guaifenesin 50 MG / pseudoephedrine HCl 15 MG per 5 ML Oral SolutionSY6

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63102-102-162023-10-18C16284748780-10191ceaa-62b9-198a-e063-dbdaa90aec3eACTINEL ® Pediatric
63102-102-162023-07-28C16284748780-10191ceaa-62b9-198a-e063-dbdaa90aec3eACTINEL ® Pediatric

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-102-16ACTINEL PEDIATRIC474 mL in 1 BOTTLESOLUTION4746

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63102-102-16ML - Milliliter63102-102528ff6bd-850c-4865-8444-e57cfbd143cd12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH1
GUAIFENESINACTIVE INGREDIENT495W7451VQ1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8N1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS1
GUAIFENESINACTIVE MOIETY495W7451VQ1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9F1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6N1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
63102-10263102-102-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE6V9V2RYJ8NACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
POTASSIUM CITRATEEE90ONI6FFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSOLUTION / ORAL750 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / ORAL660 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CORN SYRUPCORN SYRUP9G5L16BK6NSOLUTION / ORAL750 mg/5mlExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 PEDIATRICDEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCLACTIPHARMA, LLC6bb92d74-4893-40b8-af58-eb307155e8762025-07-08WarningsExact identifier
ndc (package): 63102-102-16
ndc (product): 63102-102
ndc11 (package): 63102010216
spl id: eb2ae74b-0abd-4451-a6a3-f2c5b0fbcfbf
spl set id: 6bb92d74-4893-40b8-af58-eb307155e876

Reported adverse events (FAERS/openFDA)#

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