Trispec Dmx Cough Suppressant Expectorant Peach Flavor
FDA Label NDC 58238-227
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 Dmx Cough Suppressant Expectorant Peach Flavor (NDC 58238-227). 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 trispec dmx cough suppressant expectorant peach flavor, active ingredients (in each 5 ml teaspoonful), purpose, uses, warnings, do not use if, otc - ask doctor, 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
Purpose
Cough suppressant
Expectorant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
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.
Otc - Ask Doctor
Ask a doctor before use if you have
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
- cough accompanied by excessive phlegm (mucus)
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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.
Dosage & Administration
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.
- do not use enclosed measuring cup for any other drug product
Storage And Handling
Other Information
- Store at room temperature 15°C-30°C (59°F-86°F)
Inactive Ingredient
Inactive Ingredients
Bitter Mask, Citric Acid, Maltitol, Peach Flavor, Propylene Glycol, Purified Water, Sodium Citrate, Sorbitol, Sucralose
Otc - Questions
Questions? Call 1-787-701-3312. You may also report serious side effects to this phone number.
Trispec Dmx Cough Suppressant Expectorant Peach Flavor 4 Oz/118 Ml (58238-227-04)
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