Giltuss Bucalsep
85053391-8d71-ab4f-e053-2991aa0a7e08
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Warnings and Precautions
Warnings
Indications and Usage
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
Dosage and Administration
Directions
Adults and children 2 years of age and older:
- 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
Children under 2 years of age:consult a dentist or doctor
Description
Drug Facts
Section 42229-5
Drug Facts
Section 44425-7
Other information
- Tamper evident:Do not use if safety seal is broken or missing
- Store at room temperature
Section 50565-1
Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Section 50566-9
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
Section 50567-7
When using this product, do not exceed recommended dosage
Section 50568-5
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
Section 50570-1
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
Section 51727-6
Inactive ingredients: Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose
Section 51945-4
MAXIMUM STRENGTH
Oral Spray
Giltuss BUCALSEP®
SORE THROAT AND ORAL INFECTIONS
ALCOHOL FREE. SUGAR FREE. DYE FREE
RELIEVES
- SORE THROAT
- THROAT INFECTION
- CANKER SORES
- OTHER ORAL PAINS AND INJURIES
SPEARMINT FLAVOR
1FL OZ (30 mL)
Section 53413-1
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.
Section 53414-9
If pregnant or breast-feeding,ask a health professional before use.
Section 55105-1
Purposes
Anesthetic
Astringent
Anesthetic
Section 55106-9
Active ingredients (in each 30 mL)
Benzocaine, 6.5% (1950 mg)
Zinc Chloride, 0.12% (36 mg)
Menthol, 0.1% (30 mg)
Structured Label Content
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
Directions
Adults and children 2 years of age and older:
- 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
Children under 2 years of age:consult a dentist or doctor
Warnings and Precautions (34071-1)
Warnings
Section 42229-5 (42229-5)
Drug Facts
Section 44425-7 (44425-7)
Other information
- Tamper evident:Do not use if safety seal is broken or missing
- Store at room temperature
Section 50565-1 (50565-1)
Keep out of reach of children.In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)
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
Section 50567-7 (50567-7)
When using this product, do not exceed recommended dosage
Section 50568-5 (50568-5)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive ingredients: Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose
Section 51945-4 (51945-4)
MAXIMUM STRENGTH
Oral Spray
Giltuss BUCALSEP®
SORE THROAT AND ORAL INFECTIONS
ALCOHOL FREE. SUGAR FREE. DYE FREE
RELIEVES
- SORE THROAT
- THROAT INFECTION
- CANKER SORES
- OTHER ORAL PAINS AND INJURIES
SPEARMINT FLAVOR
1FL OZ (30 mL)
Section 53413-1 (53413-1)
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.
Section 53414-9 (53414-9)
If pregnant or breast-feeding,ask a health professional before use.
Section 55105-1 (55105-1)
Purposes
Anesthetic
Astringent
Anesthetic
Section 55106-9 (55106-9)
Active ingredients (in each 30 mL)
Benzocaine, 6.5% (1950 mg)
Zinc Chloride, 0.12% (36 mg)
Menthol, 0.1% (30 mg)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:02.033727 · Updated: 2026-03-14T23:12:59.392851