FDA Label for Broncochem Kids Cold And Flu
View Indications, Usage & Precautions
Broncochem Kids Cold And Flu Product Label
The following document was submitted to the FDA by the labeler of this product Laboratorio Magnachem International Srl. 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.
Warnings
Liver warnings: this producto contains acetaminophen; severe liver damage may occur if you take:
More than 4 doses in 24 hour, wich is the maximum daily amount for this product.
With other drugs containing acetaminophen.
Sore throat warnings: if sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nauseas or vomiting, consult a doctor promptly.
allergy warnings: acetaminophen may cause severe skin reactions; symptoms may include:
Sking reddening, blisters, rash. If sking reactions occurs, stop use and seek medical attention.
Uses
Bronchial congestion, irritation of the respiratory passages, helps loosen phlegm (mucus) and dilute bronchial secretions, temporarily reduces fever and minor pains associated with cold, headache, and sore throat.
Active Ingredients
Acetaminophen...................325.00mg
Guaifenesin........................200.00mg
Phenylephrine HCl..................5.00mg
Ask A Doctor Before Use If Your Kid Have
Liver disease
Persistent or chronic cough, asthma or emphysema
If your kid is allergic to acetaminophen or any other componet of this formula
Stop Use And Ask A Doctor If
Symtoms last more than 5 days
Fever gets worst or last more than 3 days, or occurs with rash or headache that last, a persistent cough, this could be signs of a serious conditions
If your child is taking the bloood thinning drug warfarin
Keep Out Of The Reach Of Children
Keep out of the reach of children
Overdose Warning
In case of accidental overdose. seek professional assistance or contact a poison control center inmediately
Directions
Take only as directed, for your convenience a dosage spoon is provided. Do not exceed 4 doses in a 24 hour period
Children from 6 to 12 years-----10mL or cc every 6 hours
Children form 2 to 6 years------5mL or cc every 6 hours
Children under 2 years, ask your doctor
Other Information
store at 66-77*F (20-25*C), do not use if securety cap is altered or broken
Inactive Ingredients
Propylene glycol, glycerin, Sorbitol USP, Sucralose, Citric acid, disodium Hedta, Povidone, Sodium citrate dihydrate, Sodium chloride, Honey, Propyl gallate, FD&C Red #40, Aloe Vera, Methylparaben USP, Propylparaben USP, Bubble Gum flavor, Raspberry flavor, Nat. Masking type #27872, Purified water.
Quiestions?
1-561-338-5221 or visit us at www.broncochem.com
Purose
Acetaminophen...........Analgesic
Guaifenesin................Expectorant
Phenylephrine.............Decongestant
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