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| Product NDC Code | 67172-018 | ||||
|---|---|---|---|---|---|
| Drug Name | Chloraseptic warming sore throat |
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| Type | Brand | ||||
| Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | LOZENGE | ||||
| RxCUI drug identifier | 199071, 1245378 |
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| Application Number | M022 | ||||
| Labeler Name | Prestige Brands Holdings, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active i ngredient (in each lozenge) Benzocaine 15 mg
Active Ingredients (in each lozenge) Benzocaine 15 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive i ngredients corn syrup, FD&C yellow no. 5, flavor, glycerin, honey, propylene glycol, soy lecithin, sucrose, water
Inactive Ingredients Corn Syrup, Epigallocatechin Gallate (EGCG), FD&C Blue #1, FD&C Yellow #5, Flavor, Honey, Propylene Glycol, Soy Lecithin, Sucrose, Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Temporarily relievesoccasional minor irritation, pain, sore throat and sore mouth
Uses Temporarily relieves: occasional minor irritation, pain, sore throat and sore mouth
Purpose
Information about the drug product’s indications for use.Purpose Oral Anesthetic/Analgesic
Purpose Oral Anesthetic/Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Chloraseptic Warming Sore Throat Benzocaine BENZOCAINE BENZOCAINE CORN SYRUP FD&C YELLOW NO. 5 GLYCERIN HONEY PROPYLENE GLYCOL LECITHIN, SOYBEAN SUCRALOSE WATER C Chloraseptic Warming Sore Throat Benzocaine BENZOCAINE BENZOCAINE CORN SYRUP EPIGALLOCATECHIN GALLATE FD&C BLUE NO. 1 FD&C YELLOW NO. 5 HONEY PROPYLENE GLYCOL LECITHIN, SOYBEAN SUCRALOSE WATER Green Tea C
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL Chloraseptic © warming SORE THROAT FAST ACTING HONEY LEMON 18 lozenges Chloraseptic© warming SORE THROAT FAST ACTING HONEY LEMON 18 lozenges
PRINCIPAL DISPLAY PANEL SOOTIHNG LIQUID CENTER Pharmacist #1 Recommended Chloraseptic warming SORE THROAT Benzocaine Oral Anesthetic | Analgesic Lo zenges 18 lozenges | Green Tea with real honey SOOTIHNG LIQUID CENTER Pharmacist #1 Recommended Chloraseptic warming SORE THROAT Benzocaine Oral Anesthetic | Analgesic Lozenges 18 lozenges | Green Tea with real honey
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other i nformation Store between 59 º F and 86 º F (15 º C - 30 º C). Protect from moisture. Check expiration date before using. Contains FD&C yellow no. 5 (tartrazine) as a color additive.
Other Information Store between 59 º F and 86 º F (15 º C - 30 º 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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-552-7932 C hloraseptic.com Drug Facts
Questions? 1-800-552-7932 or www.chloraseptic.com
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not exceed recommended dosage.
When using this product: do not exceed recommended dosage.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a doctor before use.
If pregnant or breast-feeding, ask a doctor before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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. 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.
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. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API