Drugplain

Giltuss Bucalsep 6.5 mg/100mL

Benzocaine, Menthol, Zinc chloride · SPRAY · Dextrum Laboratories Inc.

No Recall History
Plain English

Giltuss Bucalsep is a spray containing benzocaine, menthol, zinc chloride at 6.5 mg/100mL, taken oral. Manufactured by Dextrum Laboratories Inc..

Key Facts

Brand Name
Giltuss Bucalsep
Generic Name
Benzocaine, Menthol, Zinc chloride
NDC Code (Product)
65852-015
Manufacturer
Dextrum Laboratories Inc.
Strength
6.5 mg/100mL
Dosage Form
SPRAY
Route
ORAL, TOPICAL
Marketing Status
Application #
M022
Drug Class
Standardized Chemical Allergen [EPC]; Copper Absorption Inhibitor [EPC]
Marketing Start
07/26/2018

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Indication and usage section Indication and usage section Adults and children 2 years of age and older apply to affected area gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use 4 times daily or as directed by dentist or doctor children under 12 years of age should be supervised in the use of the product Children under 2 years of age: do not use indication an user

Dosage & Administration

Directions Directions: Adults and children 2 years of age and older apply to affected area gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use 4 times daily or as directed by dentist or doctor children under 12 years of age should be supervised in the use of the product Children under 2 years of age: do not use Directions

Warnings

Warnings Warnings Do not use IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuosly for 10 minutes. Seek immediate medical attention if pain or irritations persists. this product for more than 7 days unless directed by a doctor or a dentist Methemoglobinemia Warning: use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before.Stopo use and seek immediate medical attention if you or a child in your care develops: pale, gray or blue colored skin ( cyanosis) headache rapid heart rate shortness of breath dizziness or lightheadedness fatigue or lack of energy Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetic Allergy alert Warnings

Frequently Asked Questions

What is Giltuss Bucalsep used for?

Giltuss Bucalsep contains Benzocaine, Menthol, Zinc chloride. It is a spray taken oral. Consult your doctor for specific uses.

Is Giltuss Bucalsep a controlled substance?

Giltuss Bucalsep is not classified as a controlled substance by the DEA.

What is the generic name for Giltuss Bucalsep?

The generic name for Giltuss Bucalsep is Benzocaine, Menthol, Zinc chloride. There are 3 other brand versions of Benzocaine, Menthol, Zinc chloride.

What is the NDC code for Giltuss Bucalsep 6.5 mg/100mL?

The NDC (National Drug Code) for Giltuss Bucalsep 6.5 mg/100mL is 65852-015, listed by Dextrum Laboratories Inc..

Product NDC

65852-015

Package NDC

65852-015-01

Other Giltuss Bucalsep Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)