Label: ACTIDOM DA- chlorpheniramine maleate, phenylephrine hydrochloride solution
- NDC Code(s): 63102-115-16
- Packager: Actipharma, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 20, 2022
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- Drug Facts
- Active Ingredients (in each 5 mL tsp)
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
When using this product • do not exceed recommended dosage
• excitability may occur, especially in children
• may cause drowsiness
• do not give this product to children who are taking sedatives of tranquilizers, without first consulting the child's doctor
Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occur
• symptoms do not improve within 7 days or are accompanied by fever. These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- Other information
- Inactive ingredients
- Questions or comments?
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Dometuss® - DA*
SUGAR & ALCOHOL FREE
*Dometuss® DA is registered trademark of Domel Laboratories. This product is not manufactured, distributed or marketed by Domel Laboratories.
Manufactured in the USA for
ActiPharma, Inc. San Juan, PR 00917
INGREDIENTS AND APPEARANCE
chlorpheniramine maleate, phenylephrine hydrochloride solution
Product 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 final part341 01/20/2022 Labeler - Actipharma, Inc (079340948)