TRISPEC DMX COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR- dextromethorphan hydrobromide, guaifenesin liquid

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
- 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 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.
PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact 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.

STORAGE AND HANDLING
Other Information
- Store at room temperature 15ºC-30ºC (59ºF-86ºF)
INACTIVE INGREDIENT

Inactive Ingredients

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

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 COUGH SUPPRESSANT EXPECTORANT PEACH FLAVOR
dextromethorphan hydrobromide, guaifenesin liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 58238-227-04	1 in 1 PACKAGE	11/18/2014
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	11/18/2014

Labeler - Deliz Pharmaceutical Corp (826391138)

Name	Address	ID/FEI	Business Operations
Establishment
Woodfield Pharmaceutical, LLC		079398730	manufacture(58238-227)

TRISPEC DMX Cough Suppressant Expectorant Peach Flavor by