Label: GOYESCAS 7 SYRUPS ALCOHOL AND SUGAR FREE COUGH AND COLD- dextromethorphan, guaifenesin, phenylephrine liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11856-0031-1 - Packager: GOYESCAS OF FLA
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 19, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Dosage & Administration
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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.
- Inactive Ingredients
- Use
- Purpose
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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.
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PRINCIPAL DISPLAY PANEL
Drug Facts
Active Ingredients: Purpose
(in each 5 ml. tsp)
Dextromethorphan HBr USP 10mg Cough Suppresant
Guaifenesin USP 100mg 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:
Caramel Color, Flavor, Glycerin, Kola Extract, Methylparaben, Propylene Glycol, Propylparaben, Purified Water and sucralose.
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INGREDIENTS AND APPEARANCE
GOYESCAS 7 SYRUPS ALCOHOL AND SUGAR FREE COUGH AND COLD
dextromethorphan, guaifenesin, phenylephrine liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11856-0031 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11856-0031-1 1 in 1 BOX 1 177 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/01/2006 Labeler - GOYESCAS OF FLA (032506248)