Active Ingredients
Drug Facts
Active Ingredients: Purpose
(in each 5 ml. tsp)
Dextromethorphan HBr USP 10mg Cough Suppresant
Guaifenesin USP 50mg Expectorant
Phenylephrine HCI USP 5mg Nasal Decongestant
Goyescas 7 Syrups Original
FDA Label NDC 11856-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Goyescas Of Fla for the product Goyescas 7 Syrups Original (NDC 11856-0001). 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 active ingredients, directions & dosage, warnings, inactive ingredients, use, purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Directions & Dosage
Directions:
Dose as follows or as directed by a doctor. For adults and children 12 years of age and older, 1 tablespoonful every 6 hours. For children 6 to under 12 years of age, 1 teaspoonful every 6 hours. For children under 6 years of age, consult a Physician.
Warnings
Warnings:
Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center Immediately.
Warnings:
Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach of children. In case of overdose get medical help or contact a Poison Control Center Immediately.
Inactive Ingredients
Inactive Ingredients:
Althea F.E, Caramel Color, Citric Acid, FD&C Red #40, Flavor, Glycerin, Licorice Root F.E, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tolu F.E, Wild Cherry F.E and sucrose.
Use
USE:
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves these symptoms occurring with a cold, nasal congestion, cough due to minor throat and bronchial irritation.
Purpose
Active Ingredients: Purpose
(in each 5 ml. tsp)
Dextromethorphan HBr USP 10mg Cough Suppresant
Guaifenesin USP 50mg Expectorant
Phenylephrine HCI USP 5mg Nasal Decongestant
Package Label.Principal Display Panel
Drug Facts
Active Ingredients: Purpose
(in each 5 ml. tsp)
Dextromethorphan HBr USP 10mg Cough Suppresant
Guaifenesin USP 50mg Expectorant
Phenylephrine HCI USP 5mg Nasal Decongestant
USE:
Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes. Temporarily relieves these symptoms occurring with a cold, nasal congestion, cough due to minor throat and bronchial irritation.
Warnings:
Do not use if you are now taking certain drugs for depression, psychiatric or emotional conditions or Parkinson’s disease (MAOI) or for two (2) weeks after stopping (MAOI) drugs. Stop and ask a doctor if cough lasts more than 7 days, if cough comes back or occurs with fever, rash or headache that lasts. Ask a doctor if you are pregnant or breast-feeding. Keep out of reach children. In case of overdose get medical help or contact a Poison Control Center Immediately.
Directions:
Dose as follows or as directed by a doctor. For adults and children 12 years of age and older, 1 tablespoonful every 6 hours. For children 6 to under 12 years of age, 1 teaspoonful every 6 hours. For children under 6 years of age, consult a Physician.
Inactive Ingredients:
Althea F.E, Caramel Color, Citric Acid, FD&C Red #40, Flavor, Glycerin, Licorice Root F.E, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Tolu F.E, Wild Cherry F.E and sucrose.
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