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NDC 63102-0115-16 ACTIDOM DA 1; 2.5 mg/5mL; mg/5mL Details
ACTIDOM DA 1; 2.5 mg/5mL; mg/5mL
ACTIDOM DA is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Actipharma, Inc. The primary component is CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 63102-0115-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Chlorpheniramine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 63102-0115-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63102-0115 |
|---|---|
| Product ID | 63102-115_42ab8014-a853-4d7a-a56d-5f4b96bbd9a5 |
| Associated GPIs | |
| GCN Sequence Number | 062636 |
| GCN Sequence Number Description | chlorpheniramine/phenylephrine LIQUID 1-2.5 MG/5 ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 98410 |
| HICL Sequence Number | 000446 |
| HICL Sequence Number Description | CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | ACTIDOM DA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Chlorpheniramine maleate, Phenylephrine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 1; 2.5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Actipharma, Inc |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63102-0115-16 (63102011516)
| NDC Package Code | 63102-115-16 |
|---|---|
| Billing NDC | 63102011516 |
| Package | 474 mL in 1 BOTTLE, PLASTIC (63102-115-16) |
| Marketing Start Date | 2022-01-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7797c22e-ffeb-4798-9fb6-aa64cf077ba7 Details
Uses
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
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.
Directions
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
Contains the same active ingredients as Dometuss® - DA*
SUGAR & ALCOHOL FREE
Great Flavor
*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
www.actipharma.net
INGREDIENTS AND APPEARANCE
| ACTIDOM DA
chlorpheniramine maleate, phenylephrine hydrochloride solution |
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| Labeler - Actipharma, Inc (079340948) |