Actidom Da Solution
FDA Label NDC 63102-115
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 Actidom Da (NDC 63102-115). 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), purposes, 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)
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
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions
• do not take more than 6 doses in any 24-hour period.
| Children under 6 to under 12 years of age | Take 2 teaspoon (10 mL), every 4 hours |
| Children under 6 years of age | Consult a doctor |
Other Information
• Store at controlled room temperature: 15°-30°C (59°-86°F).
• Tamper Evident Feature: Do not use if inner seal is torn, broken or missing.
Inactive Ingredients
Citric acid, D&C Red 33, hydroxyethyl cellulose, flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate and sucralose.
Questions Or Comments?
call weekdays from 8AM to 4PM AST at 1-787-608-0882
Packaging
Image (63102 115 16 1)
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