Drug Facts
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Broncolito Syrup
FDA Label NDC 55758-520
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Broncolito (NDC 55758-520). 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 & purposes, otc - purpose, uses, warnings, do not use, ask a doctor before use if your child has, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients & Purposes
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Otc - Purpose
Active ingredients (in each 2.5 mL) Purposes
Dextromethorphan HBr 5 mg......................Cough suppressant
Guaifenesin 50 mg...............................................Expectorant
Phenylephrine HCI 2.5 mg........................Nasal decongestant
Uses
Temporarily relieves common cold symptoms:
- stuffy nose
- nasal congestion
- cough due to minor throat and bronchial irritation
- helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
Warnings
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Do Not Use
- in a child who is 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 child’s prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask A Doctor Before Use If Your Child Has
- heart disease high blood pressure
- thyroid disease
- diabetes
- a cough that is accompanied by excessive phlegm (mucus)
- a persistent or chronic cough such as occurs with smoking, asthma
When Using This Product
do not exceed recommended dosage
Stop Use And Ask A Doctor If Your Child Has
- nervousness, dizziness, or sleeplessness occur
- a persistent cough or symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- only use the dosage cup included
- do not exceed 6 doses in 24 hours
| Age | Dose |
| children 6 to under 12 years | take 5 mL every 4 hours |
| children 2 to under 6 years | take 2.5 mL every 4 hours |
| children under 2 years | consult a doctor |
Other Information
- each 2.5 mL contains: sodium 1.5 mg
- store between 68-77°F (20-25°C)
Inactive Ingredients
anhydrous citric acid, FD&C yellow #6, flavor, glycerin, honey, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
Questions?
+1-866-359-3478 (M-F) 9 AM - 5 PM EST or www.pharmadel.com
Dist By/ Por:
PHARMADEL LLC
New Castle, DE 19720
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