FDA Label for Supress Dx Pediatric Drops
View Indications, Usage & Precautions
Supress Dx Pediatric Drops Product Label
The following document was submitted to the FDA by the labeler of this product Kramer Novis. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 openingsand 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 glandDo 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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