Deltuss Dmx Cough Suppressant Nasal Decongestant Antihistamine Grape Flavor
FDA Label NDC 58238-225
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 Deltuss Dmx Cough Suppressant Nasal Decongestant Antihistamine Grape Flavor (NDC 58238-225). 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, otc - do not use, ask a doctor before use if, ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers, 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)
Dexchlorpheniramine maleate, USP 1 mg
Dextromethorphan HBr, USP 15 mg
Pseudoephedrine HCl, USP 30 mg
Purpose
Antihistamine
Cough suppressant
Nasal Decongestant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- Temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itching of the nose or throat
- itchy, watery eyes
- Temporarily restores freer breathing through the nose
Warnings
Otc - Do Not Use
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
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- difficulty in urination due to enlarged prostrate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough accompanied by excessive phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are Taking Sedatives Or Tranquilizers
When Using This Product
- do not exceed recommended dosage
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- avoid alcoholic beverages
- use caution when driving a motor vehicle or operating machinery
- excitability may occur especially in children
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 accompanied 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 6 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 6 hours not to exceed 4 teaspoonfuls in 24 hours, or as directed by a doctor.
|
| Children 2 to under 6 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.
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