TRISPEC PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR- dextromethorphan hydrobromide, guaifenesin, 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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TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 187 mg
Pseudoephedrine HCl, USP 30 mg

Purpose

Cough suppressant

Expectorant

Nasal decongestant

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

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

_____________________________________________________________________________________________

When using this product

  • do not exceed recommended dosage

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 acompanied 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

■ use only with enclosed measuring cup

■ do not use enclosed measuring cup for any other drug product

Adults and children 12 years of age and older:

2 teaspoonfuls (tsp) every 4 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 4 hours not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.

Children 2 to under 6 years of age:

½ teaspoonful (tsp) every 4 hours not to exceed 2 teaspoonfuls in 24 hours, or as directed by a doctor.

Other Information

Inactive ingredients

Bitter Mask, Citric Acid, 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

Trispec PSE Labeling 1

Trispec PSE Labeling 2

TRISPEC PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR 
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58238-228
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
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (Grape Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58238-228-041 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(58238-228)

Revised: 11/2021
Document Id: cfd4cd0a-66f2-581d-e053-2995a90a7da9
Set id: 4d6c75fa-a109-4ccc-ad1d-ffdc01080601
Version: 6
Effective Time: 20211102
 
Deliz Pharmaceutical Corp