ACTIDOM DA

Manufacturer
ACTIPHARMA, LLC
Effective date
2024-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:16:58

Label at a glance#

ProductACTIDOM DA
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and 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

Dosage and administration

 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

Storage and handling

• 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.

Label contents#

Full prescribing information#

Active ingredients (in each 5 mL tsp)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine Maleate 1 mg
Phenylephrine HCL 2.5 mg

Purposes

OTC - PURPOSE SECTION

Antihistamine
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

citric acid, D&C Red 33, flavor, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Questions or comments?

OTC - QUESTIONS SECTION

+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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACTIDOM DAACTIDOM DA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1429345chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG in 5 mL Oral SolutionPSN2
1429345chlorpheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD2
1429345chlorpheniramine maleate 1 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63102-115-16ACTIDOM DA474 mL in 1 BOTTLE, PLASTICSOLUTION4742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63102-115ACTIDOM DA (CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [ACTIPHARMA, LLC]2Current NDC, Legacy NDC, 1 package rows20240809_7797c22e-ffeb-4798-9fb6-aa64cf077ba7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63102-11563102-115-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACTIDOM DACHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC7797c22e-ffeb-4798-9fb6-aa64cf077ba72024-07-15WarningsExact identifier
ndc (package): 63102-115-16
ndc (product): 63102-115
ndc11 (package): 63102011516
spl id: e2d0fae5-74da-4a40-8e64-708a3d237ea8
spl set id: 7797c22e-ffeb-4798-9fb6-aa64cf077ba7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.