Actinel Pediatric Solution
FDA Label NDC 63102-102
12 label sections · Submitted to the FDA by Actipharma, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Actipharma, Llc for the product Actinel Pediatric (NDC 63102-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each 5 ml tsp), purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - Keep Out Of Reach Of Children
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.
| 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 |
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
Other
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 (6310210216 1)
* Please review the disclaimer below.
