FDA Label for Chloraseptic Sore Throat Liquid Center
View Indications, Usage & Precautions
Chloraseptic Sore Throat Liquid Center 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 Ingredients
(in each lozenge)
Benzocaine 6 mg
(in each lozenge)
Menthol 10 mg
(in each lozenge)
Benzocaine 6 mg
(in each lozenge)
Menthol 10 mg
(in each lozenge)
Benzocaine 6 mg
(in each lozenge)
Menthol 10 mg
Purpose
Oral Anesthetic/Analgesic
Oral Anesthetic/Analgesic
Oral Anesthetic/Analgesic
Oral Anesthetic/Analgesic
Oral Anesthetic/Analgesic
Oral Anesthetic/Analgesic
Uses
Temporarily relieves:
- occasional minor irritation, pain, sore throat and sore mouth
- occasional minor irritation, pain, sore throat and sore mouth
- occasional minor irritation, pain, sore throat and sore mouth
Temporarily relieves:
Temporarily relieves:
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 6 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 6 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 6 years of age unless directed by a doctor.
When Using This Product:
do not exceed recommended dosage.
do not exceed recommended dosage.
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
- sore mouth symptoms do not improve in 7 days
- irritation, pain or redness persists or worsens
- swelling, rash or fever develops
- 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 health care professional before use.
ask a health care professional before use.
ask a health care professional before use.
Keep Out Of Reach Of Children.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
In case of overdose or accidental poisoning, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
- Children under 6 years of age: Consult a doctor or dentist.
- Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
- Children under 6 years of age: Consult a doctor or dentist.
- Adults and children 6 years of age and over: Take 1 lozenge every 2 hours as needed. Allow lozenges to dissolve slowly in the mouth.
- Children under 6 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.
- Tamper Evident: Do not use if blister package with “Chloraseptic®” name has been disturbed or opened.
- 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.
- 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 Red #40, Flavor, Glycerine, Soy Lecithin, Sucrose, Water
Corn Syrup, FD&C Red #40, FD&C Yellow #6, Flavor, Glycerine, Propylene Glycol, Soy Lecithin, Sucrose, Water
Corn Syrup, FD&C Yellow #5, Flavor, Glycerine, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Water
Questions?
1-800-552-7932 or www.chloraseptic.com
Drug Facts
Chloraseptic Citrus Lozenges
1-800-552-7932 or www.chloraseptic.com
Drug Facts
Chloraseptic Honey Lemon Lozenges
1-800-552-7932 or www.chloraseptic.com
Principal Display Panel
Chloraseptic®
SORE THROAT
18 lozenges | Cherry
Chloraseptic®
SORE THROAT
18 lozenges | Citrus
Chloraseptic®
SORE THROAT
18 lozenges | Honey Lemon with real honey
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