DOMETUSS-G- guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet 
DOMEL

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-G

Drug Facts

Active ingredients (in each tablet)Purpose
Guaifenesin200 mgExpectorant
Dextromethorphan HBr20 mgCough Suppressant
Phenylephrine HCl10 mgNasal Decongestant

Uses

Warnings

If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor.

Do not use

  • if you are now taken a prescription Monoaminoxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for two weeks after stopping the MAOI drug; If you do not know if you are taking a prescription drug that contains an MAOI, ask a doctor or pharmacist before taking this product

Do not take this product: for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus), unless directed by a doctor.

Do not give this product if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask a doctor before use if you have

  • liver disease
  • if you are taking the blood thinning drug warfarin.

Stop using this product and ask a doctor if

  • new symptoms occur
  • symptoms do not improve within 7 days or are accompanied by fever.
  • pain or fever persists or gets worse. These could be signs of a serious condition

Keep out of reach of children.

If you are pregnant or breast-feeding, ask a health professional before use.

Directions

Do not take more than 6 doses in any 24 hours period.

AgeDose
adults and children 12 years of age and over1 tablets every 4 hours.
children 6 to 12 years of age1/2 tablet every 4 hours.
children under 6 years of ageConsult a doctor.

Other information

Tamper evident

Do not use if there is evidence of tampering.

Inactive ingredients

Dicalcium phosphate, magnesium stearate, maltodextrin, mirocrystalline cellulose, povidone, silicon dioxide, stearic acid, talc.

Questions or comments?

Calle de Diego #488
San Juan P.R. 00924

Phone: 787-767-3246
For more information visit
www.domelpharma.com

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 53809-250-01

DOMETUSS-G

DEXTROMETHORPHAN HBr/
PHENYLEPHRINE HCl / GUAIFENESIN

100 TABLETS

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
DOMETUSS-G 
guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-250
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code D2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53809-250-01100 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2019
2NDC:53809-250-044 in 1 BOTTLE; Type 0: Not a Combination Product11/11/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/11/2019
Labeler - DOMEL (808198837)

Revised: 5/2020
Document Id: dc4a9eb6-1eb6-46ed-b51d-ef80ec05e694
Set id: 19e06e4d-9efb-4059-a33d-4a89c3a2534c
Version: 1
Effective Time: 20200501
 
DOMEL