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, LLC. 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

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.

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

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

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.

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

SPL UNCLASSIFIED SECTION

Sugar & Alcohol FREE

Great Flavor

Manufactured in USA with imported ingredients
for ActiPharma.
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 Drug	M012	01/20/2022

Labeler - ACTIPHARMA, LLC (079340948)