Otc - Active Ingredient
Active Ingredients/5 ml: brompheniramine maleate 4 mg, dextromethorphan hydrobromide 20 m, phenylephrine hydrochloride 10 mg
Presgen B Syrup
FDA Label NDC 52083-637
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kramer Novis for the product Presgen B (NDC 52083-637). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Decongestant, antihistamine, antitussive (anti cough)
Indications & Usage
: relieves nasal congestion associated with sinusitis. relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies. relieves sinus congestion and pressure ,helps decongest sinus openings and passages. restores free breathing. suppresses cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants. relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergie
Warnings
WarningsA persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor
Do not:Use more than the recommended dose. Give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctorMay cause excitability especially in children
Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland
May cause drowsiness: alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery
when using this product do not exceed recommended dose
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 MAOI drug
. If you do not know if your prescription drug contains an MAOI, consult a doctor or pharmacist before taking this product
Stop use and ask a doctor if: symptoms do not improve, new symptoms occur, redness or swelling is present, nervousness, dizziness or sleeplessness occur, symptoms do not improve within 7 days or are accompanied by fever, cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache
Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland, persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema or where cough is accompanied by excessive phlegm (mucus)
In case of accidental overdose, contact a Poison Control center immediately
Prompt medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.
Otc - Keep Out Of Reach Of Children
Keep this and all medicines out of the reach of children
Otc - Pregnancy Or Breast Feeding
As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
Inactive Ingredient
Inactives: Citric Acid, Flavor, Glycerin, Methylparaben, propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sucralose
Package Label.Principal Display Panel
MM1
Dosage & Administration
Adults and children 12 years of age and older-Take 1 teaspoons (5 ml) every 4 hours as needed, do not exceed 6 teaspoons in 24 hours, or as directed by a doctor
Children 6-12 years, Take 1/2 teaspoon (2.5 ml) every 4 hours as needed, do not exceed 3 teaspoons in 24 hours, or as directed by a doctor
Children under 6 years, consult a physician
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