Label: ACTIDOM DA- chlorpheniramine maleate, phenylephrine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 15, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredients (in each 5 mL tsp)

    Chlorpheniramine Maleate 1 mg
    Phenylephrine HCL 2.5 mg

  • Purposes

    Antihistamine
    Nasal decongestant

  • Uses

    • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose  • sneezing  • itching of the nose or throat
    • itchy, watery eyes  • nasal congestion
    • temporarily restores free breathing through the nose

  • ​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 child has • heart disease  • diabetes  • high blood pressure  • thyroid disease  • glaucoma  • a breathing problem such as chronic bronchitis

    Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's doctor.

    When using this productdo not exceed recommended dosage  
    • may cause excitability especially in children • may cause drowsiness • sedatives and tranquilizers may increase the drowsiness effect

    Stop use and ask a doctor if  • nervousness, dizziness, or sleeplessness occur
    • 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.

  • Directions

     take every 4 hours, or as directed by a doctor.

     children 6 to under 12 years of age take 10 mL (2 tsp). Do not exceed 6 doses in 24 hours
     children under 6 years of age consult a doctor

  • Other information

    • tamper evident feature: Do not use if safety seal is torn, broken or missing.
    • store at controlled room temperature: 15°-30°C (59°-86°F).
    • avoid excessive heat or humidity.

  • Inactive ingredients

    citric acid, D&C Red 33, flavor, hydroxyethyl cellulose, 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 4 PM AST

  • SPL UNCLASSIFIED SECTION

    Sugar & Alcohol FREE

    Great Flavor

    Manufactured in USA with imported ingredients
    for ActiPharma.
    San Juan, PR 00917.
    www.actipharma.net

  • Packaging

    ACTIDOM DA

  • INGREDIENTS AND APPEARANCE
    ACTIDOM DA 
    chlorpheniramine maleate, phenylephrine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63102-115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Colorpink (LIGHT PINK) Score    
    ShapeSize
    FlavorBANANA, STRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63102-115-16474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01201/20/2022
    Labeler - ACTIPHARMA, LLC (079340948)