GOYESCAS 7 SYRUPS SORE THROAT RELIEF- benzocaine liquid

Goyescas 7 Syrups by

Drug Labeling and Warnings

Goyescas 7 Syrups by is a Otc medication manufactured, distributed, or labeled by GOYESCAS OF FLA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage & Administration

Directions

Adults and children 2 years of age and older, apply to affected area for at least one minute and then spit out. Use up to 4 times daily or as directed by doctor. Children under 12 years of age should be supervised in the used of the product. Children 2 years of age: Consult a doctor.

Warnings

Warnings

Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persist or worsens. If pregnant or breast feeding, ask a health professional before use.

Inactive Ingredients

Inactive ingredients

Benzalkonium chloride, Eucalyptus oil, FD&C Red #40, Propylene Glycol, Purified Water, Sodium Bicarbonate, Sodium Borate and sorbitol

Uses

Uses for the temporary relief of:

Occasional minor irritation, pain, sore mouth and throat. Pain due to canker sores. Pain due to minor irritation of injury of the mouth and gums, minor discomfort and protection of irritated area in sore mouth and sore throat.

Purpose

DRUG FACTS PURPOSE

Benzocaine 5% Anesthetic

Warnings

Warnings

Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persist or worsens. If pregnant or breast feeding, ask a health professional before use.

Active Ingredients

DRUG FACTS

ACTIVE INGREDIENTS PURPOSE

Benzocaine 5% Anesthetic

PRINCIPAL DISPLAY PANEL

DRUG FACTS

ACTIVE INGREDIENTS PURPOSE

Benzocaine 5% Anesthetic

Uses for the temporary relief of:

Occasional minor irritation, pain, sore mouth and throat. Pain due to canker sores. Pain due to minor irritation of injury of the mouth and gums, minor discomfort and protection of irritated area in sore mouth and sore throat.

Warnings

Keep away of reach from children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not exceed recommended dosage. Stop use and ask a Doctor if: Sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting, sore mouth symptoms do not improve in 7 days or if irritation, pain or redness persist or worsens. If pregnant or breast feeding, ask a health professional before use.

Directions

Adults and children 2 years of age and older, apply to affected area for at least one minute and then spit out. Use up to 4 times daily or as directed by doctor. Children under 12 years of age should be supervised in the used of the product. Children 2 years of age: Consult a doctor.

Other Information

Store at room temperature (68-77F) (20-25C)

Do not freeze

Alcohol Free

Inactive ingredients

Benzalkonium chloride, Eucalyptus oil, FD&C Red #40, Propylene Glycol, Purified Water, Sodium Bicarbonate, Sodium Borate and sorbitol.

INGREDIENTS AND APPEARANCE

GOYESCAS 7 SYRUPS  SORE THROAT RELIEF
benzocaine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11856-5003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
EUCALYPTUS OIL (UNII: 2R04ONI662)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SORBITOL (UNII: 506T60A25R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11856-5003-1	1 in 1 BOX
1		33 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	10/01/2015

Labeler - GOYESCAS OF FLA (032506248)