ACTIDOM DA- chlorpheniramine maleate, phenylephrine hydrochloride solution

ACTIDOM DA by

Drug Labeling and Warnings

ACTIDOM DA by is a Otc medication manufactured, distributed, or labeled by Actipharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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.

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

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

Packaging

INGREDIENTS AND APPEARANCE

ACTIDOM DA 
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)