The following Structured Product Label (SPL) was submitted to the FDA by Camacho Navarrete, Jose Luis for the product Bronco Plus (NDC 84370-202). 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 warnings, indications & usage, dosage & administration, dosage forms & strengths, contraindications, otc - keep out of reach of children, otc - pregnancy or breast feeding, otc - active ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Do not give this product for persistent or chronic cough such as occurs with asthma or if cough is accompanied by excesive phlegm (mucus) unles directed by a doctor.
Stop use and ask a doctor if cough persist for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache, as a persistent cough may be a sing of a serious condition.
If pregnant or breast feeding, ask a health professional before use.
For the relief of the symptoms of the common cold and cough.
Children over 2 years take one teaspoon (2.5 mL) every 6 hours during the day.
Adults: Take one jtablespoon (5 mL) every 6 hours during the day.
Oral administration.
Hypersensitivity to the components of the formula.
Do not administer to children under 2 years of age, or to diabetic patients without medical supervision.
Do not use during pregnancy and breastfeeding without medical supervision.
Keep out of reach of children. In case of overdose, get medial help or contact a Poison Control Center right away.
If pregnant or breast feeding, ask a health professional before use.
EUCALYPTUS GLOBULUS LEAF
WATER
BOUGAINVILLEA GLABRA FLOWER
MENTHA PIPERITA
VERBASCUM THAPSUS
INVERT SUGAR
For the relief of the symptoms of the common cold and cough.
84370-202-01
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