Actinel Dm Pediatric Liquid
FDA Label NDC 63102-130
Full FDA labeling including 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 Dm Pediatric (NDC 63102-130). 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 teaspoonful), 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 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.
Otc - Keep Out Of Reach Of Children
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
Packaging
Actinel Dm Pediatric (63102130 3)
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