TRISPEC PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR- dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid

TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor by

Drug Labeling and Warnings

TRISPEC PSE Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor by is a Otc medication manufactured, distributed, or labeled by Deliz Pharmaceutical Corp, Woodfield Pharmaceutical, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• temporarily relieves cough due to minor throat and bronchial irritation occuring with a cold or inhaled irritants
• helps loosen phlegm and thin bronchial secretions to make coughs more productive
• temporarily relieves nasal congestion

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

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

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

INGREDIENTS AND APPEARANCE

TRISPEC PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT GRAPE FLAVOR 
dextromethorphan hydrobromide, guaifenesin, pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58238-228
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
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	GRAPE (Grape Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58238-228-04	1 in 1 CARTON	03/20/2015
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	03/20/2015

Labeler - Deliz Pharmaceutical Corp (826391138)

Establishment
Name	Address	ID/FEI	Business Operations
Woodfield Pharmaceutical, LLC		079398730	manufacture(58238-228)