GOYESCAS BRONCOVAC 1 COUGH AND COLD- dextromethorphan, guaifenesin, phenylephrine liquid

Goyescas Broncovac 1 by

Drug Labeling and Warnings

Goyescas Broncovac 1 by is a Otc medication manufactured, distributed, or labeled by GOYESCAS OF FLA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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:

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

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.

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.

INGREDIENTS AND APPEARANCE

GOYESCAS BRONCOVAC 1  COUGH AND COLD
dextromethorphan, guaifenesin, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11856-0016
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	50 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL 1-PALMITATE (UNII: 34BD3PWM6B)
WATER (UNII: 059QF0KO0R)
CARAMEL (UNII: T9D99G2B1R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
LICORICE (UNII: 61ZBX54883)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CHERRY (UNII: BUC5I9595W)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11856-0016-1	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	08/01/1958

Labeler - GOYESCAS OF FLA (032506248)