FDA.reportPublic FDA data

ACTINEL Diabetic

Manufacturer
ACTIPHARMA, LLC
Effective date
2026-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:43:54

Label at a glance#

ProductACTINEL Diabetic
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure10 sections

Indications and uses

• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive • temporarily relieves 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  adults and children 12 years of age and over  10 mL (2 tsp) every 4 hours  children under 12 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 10 mg

Guaifenesin 100 mg

​Purposes

OTC - PURPOSE SECTION

Cough suppressant

Expectorant

​​Uses

INDICATIONS & USAGE SECTION

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

• temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

​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
• cough is accompanied by excessive phlegm (mucus)
• persistent or chronic cough such occurs with smoking, asthma, or emphysema

​When using this product
• ​do not exceed recommended dosage

​Stop use and ask a doctor if
• 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 6 doses in any 24-hour period.

• mL = milliliter, tsp = teaspoon

 adults and children 12 years of age and over 10 mL (2 tsp) every 4 hours
 children under 12 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, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

​​Questions or comments?

OTC - QUESTIONS SECTION

​1.787.608.0082

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

Call weekdays from 8AM to 4PM AST

SPL UNCLASSIFIED SECTION

Alcohol FREE

Dye FREE

Sugar FREE

Contains the same active ingredients as Tusnel®  Diabetic* 

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

Manufactured for ActiPharma
San Juan, PR 00917

Manufactured in USA with imported ingredients

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTINELDiabeticACTINELDiabetic

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN1
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY1
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-140-16ACTINEL Diabetic473 mL in 1 BOTTLE, PLASTICLIQUID4731

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63102-14063102-140-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
GUAIFENESIN495W7451VQACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SUCRALOSE96K6UQ3ZD4IACT

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 DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINACTIPHARMA, LLC35c21623-84dd-4151-b35b-e7d30b69c9c02026-01-15WarningsExact identifier
ndc (package): 63102-140-16
ndc (product): 63102-140
ndc11 (package): 63102014016
spl id: f35e67f4-4a6e-4340-9b6d-60cdbf33b412
spl set id: 35c21623-84dd-4151-b35b-e7d30b69c9c0

Reported adverse events (FAERS/openFDA)#

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