ACTINEL PEDIATRIC- dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution

ACTINEL PEDIATRIC by

Drug Labeling and Warnings

ACTINEL 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 5mL tsp)

Dextromethorphan HBr, 5mg

Guaifenesin, 50 mg

Pseudoephedrine HCl, 15 mg

Purpose

Cough Suppressant

Expectorant

Nasal Decongestant

Uses:

temporarily:
relieves nasal congestion due to common cold, hay fever or other upper respiratory allergies
relieves sinus congestion and pressure, helps decongest sinus openings and passages
restores freer breathing through the nose
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome mucus, drain bronchial tubes, and make coughs more productive
suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants

Warnings:

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.

Do not:
give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional condition, 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.
give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.

Stop use and ask a doctor if:
symptoms do not improve within 7 days or are accompanied by fever

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any sign or symptoms.

Directions:

Children 6-12 years, Take 2 teaspoons (10 ml) every 4-6 hours as needed, do not exceed 8 teaspoons in 24 hours, or as directed by a doctor.

Children 2-6 years, Take 1 teaspoon (5 ml) every 4-6 hours as needed, do not exceed 4 teaspoons in 24 hours, or as directed by a doctor.

Children under 2 years of age: consult a doctor.

Other Information

Tamper Evident: Do not use if inner seal is torn, cut, or opened.
Store at room temperature 15°- 30°C (59° - 86°F)
Avoid excessive heat or humidity.

Inactive Ingredients:

citric acid, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose

SPL UNCLASSIFIED SECTION

Contains the same active ingredients as Tusnel® Pediatric*

Dextromethorphan HBr

COUGH SUPPRESSANT

Guaifenesin

EXPECTORANT

Pseudoephedrine HCl

NASAL DECONGESTANT

ALCOHOL FREE

COST –EFFECTIVE SOLUTIONS

Manufactured in the USA for ActiPharma, Inc, Dorado, PR 00646, Tel: (787) 608-0882

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

Packaging

INGREDIENTS AND APPEARANCE

ACTINEL PEDIATRIC 
dextromethorphan hbr,guaifenesin,pseudoephedrine hcl solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63102-102
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	50 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 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	pink	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63102-102-16	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/24/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/24/2014

Labeler - Actipharma, Inc (079340948)