FDA Label for Chloraseptic Warming Sore Throat

View Indications, Usage & Precautions

ACTIVE INGREDIENT
PURPOSE
USES
WARNINGS
WHEN USING THIS PRODUCT
STOP USE AND ASK A DENTIST OR DOCTOR IF
IF PREGNANT OR BREAST-FEEDING,
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
ACTIVE INGREDIENTS
WHEN USING THIS PRODUCT:
STOP USE AND ASK A DENTIST OR DOCTOR IF:
PRINCIPAL DISPLAY PANEL

Chloraseptic Warming Sore Throat Product Label

The following document was submitted to the FDA by the labeler of this product Prestige Brands Holdings, Inc.. 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.

Active Ingredient

(in each lozenge)

Benzocaine 15 mg

Purpose

Oral Anesthetic/Analgesic

Uses

Temporarily relievesoccasional minor irritation, pain, sore throat and sore mouth

Temporarily relieves:

occasional minor irritation, pain, sore throat and sore mouth

Warnings

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” anesthetics.

Sore Throat Warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult a doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a doctor.

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” anesthetics.

When Using This Product

do not exceed recommended dosage.

Stop Use And Ask A Dentist Or Doctor If

sore mouth symptoms do not improve in 7 days
irritation, pain or redness persists or worsens
swelling, rash or fever develops

If Pregnant Or Breast-Feeding,

ask a doctor before use.

Keep Out Of Reach Of Children.

In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 3 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
Children under 3 years of age: Consult a doctor or dentist.

Adults and children 3 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
Children under 3 years of age: Consult a doctor or dentist.

Other Information

Store between 59^°F and 86^°F (15^°C - 30^°C).
Protect from moisture.
Check expiration date before using.
Contains FD&C yellow no. 5 (tartrazine) as a color additive.

Store between 59^°F and 86^°F (15^°C - 30^°C).
Protect from moisture.
Check expiration date before using.
Tamper Evident: Do not use if blister package with “Chloraseptic^®” name has been disturbed or opened.

Inactive Ingredients

corn syrup, FD&C yellow no. 5, flavor, glycerin, honey, propylene glycol, soy lecithin, sucrose, water

Corn Syrup, Epigallocatechin Gallate (EGCG), FD&C Blue #1, FD&C Yellow #5, Flavor, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Water

Questions?

1-800-552-7932 Chloraseptic.com

Drug Facts

1-800-552-7932 or www.chloraseptic.com

Active Ingredients