TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR- dextromethorphan hydrobromide, guaifenesin 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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TRISPEC DMX Cough Suppressant Expectorant Peach Flavor

TRISPEC DMX Cough Suppressant Expectorant Peach Flavor


Active ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 187 mg

Purpose

Cough suppressant

Expectorant

Uses

Warnings


Do not use 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

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough accompanied by excessive phlegm (mucus)

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.

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 Poison Control Center right away.

Directions

Other Information

Inactive Ingredients

Bitter Mask, Citric Acid, Maltitol, Peach Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralose

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

TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR 4 OZ/118 ML (58238-227-04)

Trispec DMX Labeling 1

Trispec DMX Labeling 2

TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR 
dextromethorphan hydrobromide, guaifenesin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-227
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN187 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MALTITOL (UNII: D65DG142WK)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorPEACHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58238-227-041 in 1 PACKAGE11/18/2014
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 finalpart34111/18/2014
Labeler - Deliz Pharmaceutical Corp (826391138)
Establishment
NameAddressID/FEIBusiness Operations
Woodfield Pharmaceutical, LLC079398730manufacture(58238-227)

Revised: 11/2021
Document Id: cfd4b511-8583-0b74-e053-2995a90af6c9
Set id: eee53314-655c-496b-bc01-1caa70cbf2b7
Version: 6
Effective Time: 20211102
 
Deliz Pharmaceutical Corp