Trispec Pse Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Grape Flavor

Trispec Pse Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Grape Flavor
SPL v2
SPL
SPL Set ID b4630613-c78c-4f97-bd6c-0476899f5b90
Route
ORAL
Published
Effective Date 2015-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Guaifenesin (187 mg) Pseudoephedrine (30 mg)
Inactive Ingredients
Anhydrous Citric Acid Sodium Citrate Glycerin Saccharin Sodium Propylene Glycol Water Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-02-27

Description

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

Purpose

Cough suppressant Expectorant Nasal decongestant


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 (mucus) and thin bronchial secretions to make coughs more productive

  • temporarily relieves nasal congestion

Warnings



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:

2½ mL every 4 hours not to exceed 10 mL in 24 hours, or as directed by a doctor.

Children under 2 years of age:

Consult a doctor.

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.

Drug Facts



Questions?

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

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

Inactive Ingredients

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

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

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)

Dextromethorphan HBr, USP 10 mg



Guaifenesin, USP 187 mg



Pseudoephedrine HCl, USP 30 mg

Ask A Doctor Before Use If You Have
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by excessive phlegm (mugus)

Trispec Pse Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Grape Flavor 2oz/59ml (58238 230 02)


Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occuring with a cold or inhaled irritants

  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

  • temporarily relieves nasal congestion

Purpose

Cough suppressant



Expectorant



Nasal decongestant

Warnings



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:

2½ mL every 4 hours not to exceed 10 mL in 24 hours, or as directed by a doctor.

Children under 2 years of age:

Consult a doctor.

Do Not Use (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.

Drug Facts



Questions?

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

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

Inactive Ingredients (Inactive ingredients)

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

When Using This Product (When using this product)
  • do not exceed recommended dosage
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) (Active ingredients (in each 5 mL))

Dextromethorphan HBr, USP 10 mg



Guaifenesin, USP 187 mg



Pseudoephedrine HCl, USP 30 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by excessive phlegm (mugus)

Trispec Pse Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Grape Flavor 2oz/59ml (58238 230 02) (TRISPEC PSE Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant GRAPE Flavor 2oz/59ml (58238-230-02))


Advanced Ingredient Data


Raw Label Data

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