Other
Drug Facts
MANUFACTURED FOR:
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
The following Structured Product Label (SPL) was submitted to the FDA by Gil Pharmaceutical Corp for the product Giltuss Bucalsep (NDC 58552-135). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - ask doctor/pharmacist, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
MANUFACTURED FOR:
GIL PHARMACEUTICAL CORP.
PONCE, PUERTO RICO 00717-1565
giltuss.com
Active ingredients (in each 30 mL)
Benzocaine, 6.5% (1950 mg)
Zinc Chloride, 0.12% (36 mg)
Menthol, 0.1% (30 mg)
Purposes
Anesthetic
Astringent
Anesthetic
Warnings
Do not use
Ask a doctor or pharmacist before use if you have
When using this product, do not exceed recommended dosage
Stop use and ask a doctor or dentist if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
Directions
Adults and children 2 years of age and older:
Children under 2 years of age: consult a dentist or doctor
Other information
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 ingredients:Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose
Uses
MAXIMUM STRENGTH
Oral Spray
Giltuss BUCALSEP®
SORE THROAT AND ORAL INFECTIONS
ALCOHOL FREE. SUGAR FREE. DYE FREE
RELIEVES
SPEARMINT FLAVOR
1FL OZ (30 mL)
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