DOMETUSS-DA- chlorpheniramine maleate, phenylephrine hydrochloride liquid 
Domel Laboratories

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DOMETUSS-DA

Drug Facts
Active ingredients (in each 5 mL tsp)

Chlorpheniramine Maleate 1 mg

Phenylphrine HCL 2.5 mg

Purpose

Antihistamine

Nasal Decongestant

Keep out of reach of children.

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

Uses

Warnings

Do not use this product

If pregnant or breast-feeding

as a health professional before use.

Directions

Do not exceed more than 4 doses in any 24- hour period, or as directed by a physician.

 

 
 Adults and children 12 years of age and over Take 1 teaspoonful (5 mL) every 6 hours
 Children 6 to under 12 years of age Take 1/2 teaspoonful (2.5 mL) every 6 hours
 Children under 6 years of age Ask a doctor

 

Other Information

• store at room temperature 15°-30°C (59°-86°F).

Tamper Evident: Do not use if there is evidence of tampering.

Inactive ingredients

Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben (as preserative), propylene glycol, propyl paraben (as preseratie, purified water, sodium citrate, sucralose.

Questions or comments?

Please call (787) 767-3246

DOMETUSS-DA product label

NDC 53809-206-04

DOMETUSS-DA

NASAL DECONGESTANT & ANTIHISTAMINIC

bubble gum flavor

4 fl. oz. (118 mL)

Rev: 05/13

Lot #

Exp:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

Domel Dometuss 206

DOMETUSS-DA 
chlorpheniramine maleate, phenylephrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
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    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53809-206-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/21/2016
Labeler - Domel Laboratories (808198837)
Registrant - Domel Laboratories (808198837)

Revised: 12/2022
Document Id: 0a1b6678-feef-4381-ad56-c5023e5c7f79
Set id: b5def3fb-90b9-4b7e-bb22-745804b0566a
Version: 3
Effective Time: 20221215
 
Domel Laboratories