Trispec Pse Cough Suppressant Expectorant Nasal Decongestant Grape Flavor

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Guaifenesin (187 mg) Pseudoephedrine (30 mg)

Inactive Ingredients

Citric Acid Monohydrate Propylene Glycol Water Sorbitol Glycerin Sodium Citrate Saccharin Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2015-03-20

Medication Information

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Description

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

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

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.

Drug Facts

Questions?

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

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.

Product Labels

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

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

If Pregnant Or Breastfeeding

ask a health professional before use

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

Keep Out of Reach of Children.

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

Active Ingredients (in Each 5 Ml Teaspoonful)

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 187 mg

Pseudoephedrine HCl, USP 30 mg

Structured Label Content

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

Purpose

Cough suppressant

Expectorant

Nasal decongestant

Warnings

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.

Drug Facts

Questions?

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

Do Not Use If (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.

Product Labels

Other Information

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

Inactive Ingredients (Inactive ingredients)

Bitter Mask, Citric Acid, Glycerin, Grape Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol

Ask A Doctor Before Use If (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

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use

Stop Use and Ask A Doctor If (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

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredients (in Each 5 Ml Teaspoonful) (Active ingredients (in each 5 mL teaspoonful))

Dextromethorphan HBr, USP 10 mg

Guaifenesin, USP 187 mg

Pseudoephedrine HCl, USP 30 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "Purpose": "Cough suppressant Expectorant Nasal decongestant", "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.", "Questions?": "Call 1-787-701-3312. You may also report serious side effects to this phone number.", "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.", "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", "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", "If pregnant or breastfeeding": "ask a health professional before use", "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", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredients (in each 5 mL teaspoonful)": "Dextromethorphan HBr, USP 10 mg Guaifenesin, USP 187 mg Pseudoephedrine HCl, USP 30 mg"}

Trispec Pse Cough Suppressant Expectorant Nasal Decongestant Grape Flavor

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information