Deltuss Dp Nasal Decongestant Antihistamine Cherry Flavor
FDA Label NDC 58238-226
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 Dp Nasal Decongestant Antihistamine Cherry Flavor (NDC 58238-226). 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, 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 1 mg
Pseudoephedrine HCl 30 mg
Purpose
Antihistamine
Nasal Decongestant
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other respiratory allergies
- temporarily relieves runny nose, sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever (allergic rhinitis)
- temporarily restores freer breathing through the nose
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 giving 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
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
- 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
cherry flavor, citric acid, glycerin, 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.
Deltuss Dp Nasal Decongestant Antihistamine Cherry Flavor 4Oz/118Ml (58238-226-04)
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