Giltuss Bucalsep

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each 30 mL)

Benzocaine, 6.5% (1950 mg)

Zinc Chloride, 0.12% (36 mg)

Menthol, 0.1% (30 mg)

OTC - PURPOSE SECTION

Purposes

Anesthetic

Astringent

Anesthetic

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

• IN OR NEAR THE EYES.In the event of accidental contact with the eyes, flush immediately and continuously for 10 minutes. Seek immediate medical attention if pain or irritation persists
• this product for more than 7 days unless directed by a doctor or a dentist

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you have

• a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

OTC - WHEN USING SECTION

When using this product, do not exceed recommended dosage

OTC - STOP USE SECTION

Stop use and ask a doctor or dentist if

• sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea, or vomiting
• symptoms do not improve in 7 days
• irritation, pain or redness persists or increases, or a rash appears on the skin

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and older:

Children under 2 years of age:consult a dentist or doctor

• Spray Giltuss Bucalsep several times to affected areas in the mouth or lips or as directed by a doctor or dentist
• use as a gargle or mouthwash
• gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out
• use up to 4 times daily or as directed by a doctor or dentist
• Children under 12 years of age:should be supervised in the use of this product

STORAGE AND HANDLING SECTION

Other information

• Tamper evident:Do not use if safety seal is broken or missing
• Store at room temperature

OTC - QUESTIONS SECTION

Questions or Comments?

Call 1-800-848-9114, Mon. - Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects.

INACTIVE INGREDIENT SECTION

Inactive ingredients:Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR:

GIL PHARMACEUTICAL CORP.

PONCE, PUERTO RICO 00717-1565

giltuss.com

INDICATIONS & USAGE SECTION

Uses

• for the temporary relief of occasional minor irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Oral Spray

Giltuss BUCALSEP®

SORE THROAT AND ORAL INFECTIONS

ALCOHOL FREE. SUGAR FREE. DYE FREE

RELIEVES

SPEARMINT FLAVOR

1FL OZ (30 mL)

• SORE THROAT
• THROAT INFECTION
• CANKER SORES
• OTHER ORAL PAINS AND INJURIES