Label: ACTIDOM DA- chlorpheniramine maleate, phenylephrine hydrochloride solution
- NDC Code(s): 63102-115-16
- Packager: ACTIPHARMA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 15, 2024
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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 product • do not exceed recommended dosage
• may cause excitability especially in children • may cause drowsiness • sedatives and tranquilizers may increase the drowsiness effectStop 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.
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INGREDIENTS AND APPEARANCE
ACTIDOM DA
chlorpheniramine maleate, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63102-115 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength 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 Color pink (LIGHT PINK) Score Shape Size Flavor BANANA, STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63102-115-16 474 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/20/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/20/2022 Labeler - ACTIPHARMA, LLC (079340948)