DOMETUSS-NR- dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride tablet 
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-NR

Drug Facts

Active ingredients (in each tablet)Purpose
Dextromethorphan HBr20 mgCough Suppressant
Chlorpheniramine Maleate4 mgAntihistamine
Phenylephrine HCl10 mgNasal decongestant

Uses

Warnings

Do not use

  • if you are now taken a prescription Monoaminooxidase 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.

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 problem 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.

Stop using this product and ask a doctor if

  • you get nervous, dizzy or sleepless
  • cough lasts more than 7 days, comes back or is accompanied by fever, rash or persistent headaches, these could be signs of a serious condition.

When using this product

  • Excitability may occur, especially in children
  • May cause drowsiness
  • alcohol, sedatives and tranquilizers may increase the drowsiness effect
  • Avoid alcoholic beverages while taking this product
  • Use caution when driving motor vehicle or operating machinery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults even if you do not notice signs or symptoms.

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

Directions

Do not take more than 6 tablets in 24 hours, or as directed by a doctor.

AgeDose
adults and children 12 years of age and over1 tablet every 4 hours.
children under 12 years of ageConsult a doctor before use.

Other information

Inactive ingredients

Carbomer, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Talc.

Questions or comments?

Please call (787) 767-3246

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

NDC 53809-240-01

DOMETUSS-NR

DEXTROMETHORPHAN HBr/ CHLORPHENIRAMINE
MALEATE/ PHENILEPHRINE HCl

100 TABLETS

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
DOMETUSS-NR 
dextromethorphan hydrobromide, chlorpheniramine maleate, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53809-240
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorWHITEScore2 pieces
ShapeROUNDSize13mm
FlavorImprint Code KL
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53809-240-01100 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)
Establishment
NameAddressID/FEIBusiness Operations
Lex Inc046172888MANUFACTURE(53809-240)

Revised: 12/2021
Document Id: a0119974-f4dc-4a21-8934-6a4b74f578e3
Set id: ef8abf4f-ce65-45c9-9df2-23e673c13756
Version: 1
Effective Time: 20211229
 
Domel Laboratories