Supress Dx Pediatric Drops Syrup
FDA Label NDC 52083-055

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 Supress Dx Pediatric Drops (NDC 52083-055). 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, dosage & administration, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Actives per ml: Guaifenesin 50 mg, Dextromethorphan Hydrobromide 5 mg, Phenylephrine Hydrochloride 2.5 mg

Otc - Purpose

Expectorant, antitussive (anti cough), nasal decongestant

Indications & Usage

temporarily: 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, helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passages of bothersome
mucus,drain bronchial tubes, and make coughs more productive, restores free breathing, suppresses cough due to minor
throat and bronchial irritation associated with a cold or inhaled irritants

Dosage & Administration

Children 2-6 years, Take 1 ml every 4 hours as needed, do not exceed 8 ml in 24 hours, or as directed by a doctor.Children under 2 years, consult a physician

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.Do not give this product to a child who has heart disease, high blood pressure, thyroid disease, or diabetes unless directed by a doctor.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
Do not take this product 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 diseasem, 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)

Otc - Pregnancy Or Breast Feeding

As with any drug, if you are pregnant or nursiong a baby, consult a health professional before using this product

Otc - Keep Out Of Reach Of Children

Keep this and all medicines out of the reach of children

Inactive Ingredient

Inactive Ingredients: Citric Acid, Flavor, Glycerin, Red 40, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sodium Citrate, Sodium Saccharin,

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