DOMETUSS-DMX- guaifenesin, dextromethorphan hbr, phenylephrine hcl 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-DMX

Drug Facts
Active ingredients (in each 5 mL teaspoonful) contains

Guaifenesin 200mg

Dextromethorphan HBr, USP 30 mg

Phenylephrine HCL, USP 10 mg

Purpose

Expectorant

Cough suppressant

Nasal decongestant

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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

Uses

Warnings - Do not use

Ask a doctor before use if you have

If pregnant or breast-feeding

as a health professional before use.

Stop use and ask a doctor if

These could be signs of a serious condition.

Directions

  Do not exceed recommended dosage

Do not take more than 4 doses in any 24-hour period

 

 
 age dose
 Adults and children 12 years of age and older 1 teaspoon every 6 hours
 Children under 12 years of age ask a doctor

 

Inactive ingredients

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

Other information

• Store at 15°-30° C (59°-86°F)

Questions or comments?

Please call (787) 767-3246

DOMETUSS-DMX product label

NDC 53809-203-01

DOMETUSS-DMX

COUGH SUPPRESSANT/EXPECTORANT/NASAL DECONGESTANT

Alcohol and Sugar

FREE

Grape Flavor

1 Fl. Oz. (30 mL)

Rev: 12/12

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

LOT#:/EXP.DATE:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924

Domel Dometuss 203

Domel Dometuss 203

DOMETUSS-DMX 
guaifenesin, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-203
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE30 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
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
FlavorgrapeImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53809-203-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2016
2NDC:53809-203-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2016
3NDC:53809-203-16473 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: c16cfa01-24f0-46ba-982b-d308f48ae669
Set id: 6949e1c6-df1c-451b-a1e2-9199415440f4
Version: 3
Effective Time: 20221215
 
Domel Laboratories