Trispec Pse Cough Suppressant Expectorant Nasal Decongestant Grape Flavor
FDA Label NDC 58238-228
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 Cough Suppressant Expectorant Nasal Decongestant Grape Flavor (NDC 58238-228). 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 teaspoonful), purpose, uses, warnings, do not use if, ask a doctor before use if, stop use and ask a doctor if, 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 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)
- do not exceed recommended dosage
_____________________________________________________________________________________________
When using this product
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.
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