Actidom®

Actidom®
SPL v2
SPL
SPL Set ID 7797c22e-ffeb-4798-9fb6-aa64cf077ba7
Route
ORAL
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (1 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Citric Acid Monohydrate D&c Red No. 33 Hydroxyethyl Cellulose, Unspecified Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-20

Description

Chlorpheniramine Maleate 1 mg Phenylephrine HCL 2.5 mg

Purpose

Antihistamine Nasal decongestant


Medication Information

Purpose

Antihistamine Nasal decongestant

Description

Chlorpheniramine Maleate 1 mg Phenylephrine HCL 2.5 mg

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

Section 42229-5

Sugar & Alcohol FREE

Great Flavor

Manufactured in USA with imported ingredients

for ActiPharma.

San Juan, PR 00917.

www.actipharma.net

Section 50565-1

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

Purposes

Antihistamine

Nasal decongestant

Packaging

Directions

 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

Drug Facts

​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 productdo 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.

Other Information

• 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

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

active Ingredients

Chlorpheniramine Maleate 1 mg

Phenylephrine HCL 2.5 mg

Questions Or Comments?

+1-787-608-0882

You may also report serious side effects to this phone number.

call weekdays from 8AM to 4 PM AST


Structured Label Content

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

Section 42229-5 (42229-5)

Sugar & Alcohol FREE

Great Flavor

Manufactured in USA with imported ingredients

for ActiPharma.

San Juan, PR 00917.

www.actipharma.net

Section 50565-1 (50565-1)

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

Purposes

Antihistamine

Nasal decongestant

Packaging

Directions

 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

Drug Facts

​warnings (​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 productdo 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.

Other Information (Other information)

• 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 ingredients)

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

active Ingredients (Active ingredients)

Chlorpheniramine Maleate 1 mg

Phenylephrine HCL 2.5 mg

Questions Or Comments? (Questions or comments?)

+1-787-608-0882

You may also report serious side effects to this phone number.

call weekdays from 8AM to 4 PM AST


Advanced Ingredient Data


Raw Label Data

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