DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR- dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid 
Deliz Pharmaceutical Corp

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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DELTUSS DMX Cough Suppressant Nasal Decongestant Antihistamine GRAPE Flavor

Drug Facts


Active ingredients(in each 5 mL teaspoonful)

Dexchlorpheniramine maleate, USP 1 mg
Dextromethorphan HBr, USP 15 mg
Pseudoephedrine HCl, USP 30 mg

Purpose

Antihistamine

Cough suppressant

Nasal Decongestant

Uses

Warnings


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
  • high blood pressure
  • thyroid disease
  • diabetes
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlarged prostrate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers


When using this product

  • do not exceed recommended dosage
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • excitability may occur especially in children

Stop use and ask a doctor if

  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
  • symptoms do not improve within 7 days or are accompanied by fever
  • nervousness, dizziness, or sleeplessness occur

If pregnant or breastfeeding

ask a health professional before use.

Keep out of reach of children.

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

Directions


Adults and children 12 years of age and older:
2 teaspoonfuls (tsp) every 6 hours not to exceed 8 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 6 to under 12 years of age:
1 teaspoonful (tsp) every 6 hours not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.
Children 2 to under 6 years of age:
Consult a doctor.

Other information

Inactive ingredients

Bitter Mask, Citric Acid Anhydrous, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.

Questions?

Call 1-787-701-3312. You may also report serious side effects to this phone number.

Product Labels

Deltuss DMX Labeling 1

Deltuss DMX Labeling 2

DELTUSS DMX COUGH SUPPRESSANT NASAL DECONGESTANT ANTIHISTAMINE GRAPE FLAVOR 
dexchlorpheniramine maleate, dextromethorphan hydrobromide, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-225
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXCHLORPHENIRAMINE MALEATE (UNII: B10YD955QW) (DEXCHLORPHENIRAMINE - UNII:3Q9Q0B929N) DEXCHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58238-225-041 in 1 CARTON03/20/2015
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/20/2015
Labeler - Deliz Pharmaceutical Corp (826391138)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(58238-225)

Revised: 11/2021
Document Id: cfd4bceb-ba9b-c5f7-e053-2a95a90a2faa
Set id: 783eaa30-c889-48e9-8ac6-22d3fecc84c8
Version: 6
Effective Time: 20211102
 
Deliz Pharmaceutical Corp