ACTINEL PEDIATRIC- dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution 
Actipharma, Inc

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ACTINEL® Pediatric

​Drug Facts

Active Ingredients (in each 5 mL tsp)

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

Purposes

Cough Suppressant
Expectorant
Nasal Decongestant

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 

Warnings

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.

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

Directions

• 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

• 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, Flavor, Methylparaben, Potassium Citrate, Propylene Glycol, Propylparaben, Purified Water, Sorbitol, Sucralose

Questions or comments?

call weekdays from 8AM to 4PM AST at 1.787.608.0882

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

Pediatric-102

ACTINEL PEDIATRIC 
dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN50 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POTASSIUM CITRATE (UNII: EE90ONI6FF)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63102-102-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product09/24/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01209/24/2014
Labeler - Actipharma, Inc (079340948)

Revised: 10/2023
Document Id: a07da938-ce8b-49ff-9fb5-82c4be6d0ee4
Set id: 6bb92d74-4893-40b8-af58-eb307155e876
Version: 4
Effective Time: 20231004
 
Actipharma, Inc