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
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.
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.
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.
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.
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
(in each lozenge)
Benzocaine 15 mg
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
Principal Display Panel
Chloraseptic© Warming Sore ThroatLozenges
Benzocaine Oral Anesthetic | Analgesic 18 lozenges | Honey Lemon
SOOTIHNG LIQUID CENTER
Pharmacist #1 Recommended
Chloraseptic warming SORE THROAT
Benzocaine Oral Anesthetic | Analgesic Lozenges
18 lozenges | Green Tea with real honey
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