FDA Label for Giltuss Bucalsep
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- OTC - QUESTIONS
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Giltuss Bucalsep Product Label
The following document was submitted to the FDA by the labeler of this product Gil Pharmaceutical Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
MANUFACTURED FOR:
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
Otc - Active Ingredient
Active ingredients (in each 30 mL)
Benzocaine, 6.5% (1950 mg)
Zinc Chloride, 0.12% (36 mg)
Menthol, 0.1% (30 mg)
Otc - Purpose
Purposes
Anesthetic
Astringent
Anesthetic
Warnings
Warnings
Otc - Do Not Use
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
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
When using this product, do not exceed recommended dosage
Otc - Stop Use
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
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Dosage & 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
Storage And Handling
Other information
- Tamper evident: Do not use if safety seal is broken or missing
- Store at room temperature
Otc - Questions
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
Inactive ingredients:Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose
Indications & 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
Package Label.Principal Display Panel
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)
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