Actispec Pse Solution
FDA Label NDC 63102-120
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 Actispec Pse (NDC 63102-120). 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), purpose, 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 10 mg
Guaifenesin 187 mg
Pseudoephedrine HCl 30 mg
Purpose
Cough Suppressant
Expectorant
Nasal Decongestant
Uses
• temporarily relieves cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants • helps loosen phlegm and thin bronchial secretions to make coughs more productive • temporarily relieves nasal congestion
Warnings
Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have • heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of the prostate gland • cough accompanied by excessive phlegm (mucus) • persistent or chronic cough such occurs with smoking, asthma, chronic bronchitis or emphysema.
Ask a doctor or pharmacist before use if you are 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 • nervousness, dizziness or sleeplessness occur • 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.
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 exceed more than 6 doses in any 24-hour period.
| AGE | DOSE |
| Adults and children 12 years of age and over | Take 2 teaspoonfuls (10 mL) every 4 hours |
| Children 6 to under 12 years of age | Take 1 teaspoonful (5 mL) every 4 hours |
| Children under 6 years of age | Ask physician |
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, grape flavor, methylparaben, monoammonium glycyrrhizinate, potassium citrate, propylene glycol, propylparaben, purified water, sorbitol, sucralose
Questions Or Comments?
call weekdays from 8 AM to 4PM AST at 1.787.608.0882.
Other
Contains the same active ingredients as Trispec® PSE*
Alcohol FREE
Dye FREE
Sugar FREE
Grape Flavor
Manufactured in USA with imported ingredients for ActiPharma LLC. San Juan, PR 00917. www.actipharma.net. Rev. 04/25
* Trispec® PSE is a registered trademark of Deliz Pharmaceutical Corp. This product is not manufactured, distributed or marketed by Deliz Pharmaceutical Corp.
Packaging
Actispec Pse (63102120 1)
* Please review the disclaimer below.
