ACTINEL DM PEDIATRIC- dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

ACTINEL DM Pediatric by

Drug Labeling and Warnings

ACTINEL DM Pediatric by is a Otc medication manufactured, distributed, or labeled by ACTIPHARMA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr 5 mg

Guaifenesin 75 mg

Phenylephrine HCl 2.5 mg

Purposes

Cough suppressant

Expectorant

Nasal decongestant

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

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 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.

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

Directions

 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

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

Questions or comments?

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

INGREDIENTS AND APPEARANCE

ACTINEL DM PEDIATRIC 
dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63102-130
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	75 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (Strawberry Banana)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63102-130-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/12/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/12/2026

Labeler - ACTIPHARMA, LLC (079340948)