GOYESCAS 7 SYRUPS ALCOHOL AND SUGAR FREE COUGH AND COLD- dextromethorphan, guaifenesin, phenylephrine liquid 
GOYESCAS OF FLA

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.

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Active Ingredients

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

Dosage & Administration

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.

Inactive Ingredients

Inactive ingredients:

Caramel Color, Flavor, Glycerin, Kola Extract, Methylparaben, Propylene Glycol, Propylparaben, Purified Water and sucralose.

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 100mg Expectorant

Phenylephrine HCI USP 5mg Nasal Decongestant

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.

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.

Label

Carton

GOYESCAS 7 SYRUPS ALCOHOL AND SUGAR FREE  COUGH AND COLD
dextromethorphan, guaifenesin, phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11856-0031
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN100 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARAMEL (UNII: T9D99G2B1R)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11856-0031-11 in 1 BOX
1177 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/01/2006
Labeler - GOYESCAS OF FLA (032506248)

Revised: 10/2015
Document Id: 227c1f1f-2fd7-547e-e054-00144ff88e88
Set id: 227c1f1f-2fd6-547e-e054-00144ff88e88
Version: 1
Effective Time: 20151019
 
GOYESCAS OF FLA