DOMETUSS- chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup 
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

Drug Facts

Active ingredients (in each 5 ml-teaspoonful)Purpose
Chlorpheniramine Maleate 4 mgAntihistamine
Dextromethorphan HBr 20 mgCough suppressant
Phenylephrine HCl 10 mgNasal Decongestant

USE

WARNINGS

DO NOT USE

  • to sedate a child or to make a child sleepy
  • If you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

ASK A DOCTOR BEFORE USE IF YOU HAVE

  • heart disease
  • thyroid disease
  • trouble urinating due to enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problems or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis or emphysema

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE

  • taking sedatives or tranquilizers

  • When using this product
    DO NOT EXCEED RECOMMENDED DOSAGE
  • may cause marked drowsiness
  • avoid alcoholic beverages
  • Alcohol, sedatives, and tranquilizers may cause increased drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially with children.

STOP USE AND ASK A DOCTOR IF

you get nervous, dizzy, or sleepless.

  • cough last more than 7 day, comes back, or is accompanied by fever, rash or persistent headaches. 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 exceed more than 6 doses in any 24-hour period

Adults and children 12 years of age and overTake 1 teaspoonful (5 mL) every 4 hours
Children 6 to under 12 years of ageTake 1/2 teaspoonful (2.5 mL) every 4 hours
Children under 6 years of ageAsk a doctor

Other Information

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

Tamper-Evident Disclosure

Do not use this product if aluminum foil over bottle opening is torn, broken or missing.

Inactive ingredients

citric acid,grape flavor,glycerin hydroxyethylcellulose methylparaben,propylen glycol, propylparaben, purified water,sodiumcitrate,and sucralose.

Questions or comments?

Please call (787) 767-3246

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 53809-202-04

DOMETUSS

Antihistamine/Cough Suppressant
/Nasal Decongestant

Sugar, Alcohol, And Dye
Free
Grape Flavor

4 fl. oz (118 ml)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
DOMETUSS 
chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride syrup
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-202
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
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
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53809-202-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34108/01/2015
Labeler - Domel Laboratories (808198837)

Revised: 12/2022
Document Id: 6db8a77f-ba8d-419c-8999-6ca93ab9a919
Set id: fd479126-34c4-47c2-8230-03c9b6a499f8
Version: 2
Effective Time: 20221215
 
Domel Laboratories