Giltuss Bucalsep

Giltuss Bucalsep
SPL v6
SPL
SPL Set ID 85053391-8d71-ab4f-e053-2991aa0a7e08
Routes
TOPICAL ORAL
Published
Effective Date 2019-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (6.5 g) Menthol (0.1 g) Zinc Cation (0.12 g)
Inactive Ingredients
Cetylpyridinium Chloride Spearmint Glycerin Methylparaben Propylene Glycol Propylparaben Water Sucralose

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-07-26

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

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