Trispec Pse Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Grape Flavor
FDA Label NDC 58238-230
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Deliz Pharmaceutical Corp for the product Trispec Pse Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Grape Flavor (NDC 58238-230). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients (in each 5 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 5 Ml)
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 (mucus) 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
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough accompanied by excessive phlegm (mugus)
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.
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.
|
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
Questions?
Call 1-787-701-3312. You may also report serious side effects to this phone number.
Trispec Pse Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Grape Flavor 2Oz/59Ml (58238-230-02)
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