TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR- dextromethorphan hydrobromide, guaifenesin liquid

TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor by

Drug Labeling and Warnings

TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor by is a Otc medication manufactured, distributed, or labeled by Deliz Pharmaceutical Corp, TG United Liquid, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor

Active ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 187 mg

Purpose

Cough suppressant
Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  

Warnings

Do not use

in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• persistent or chronic cough such as occurs with asthma
• 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.
  

Keep out of reach of children.

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

Directions

• For children under 6 years of age, use enclosed dropper
• do not use enclosed dropper for any other drug product
  

• Children 2 to under 6 years of age: 2.5 mL every 4 hours not to exceed 15 mL in 24 hours, or as directed by a doctor
• Children under 2 years of age: Consult a doctor.

Other information

• Store at room temperature 15°C-30°C (59°F-86°F)
  

Inactive ingredients

cherry flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, raspberry flavor, sorbitol, sucralose

Questions?

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

TRISPEC DMX Pediatric Drops Cough Suppressant Expectorant CHERRY RASPBERRY Flavor 2oz/60ml (

58238-229-02)

INGREDIENTS AND APPEARANCE

TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR 
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58238-229
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	187 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY, RASPBERRY (Cherry Raspberry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58238-229-02	1 in 1 PACKAGE
1		60 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/27/2014

Labeler - Deliz Pharmaceutical Corp (826391138)

Establishment
Name	Address	ID/FEI	Business Operations
TG United Liquid, Inc.		830980947	manufacture(58238-229)