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| Product NDC Code | 24286-1577 | ||||
|---|---|---|---|---|---|
| Drug Name | Bactimicina for 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, 1110712 |
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| Application Number | M013 | ||||
| Labeler Name | DLC Laboratories, 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 Ingredient (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 5 years of age and older: Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist. children under 5 years of age: do not use.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients dextrose, FD&C yellow #6, FD&C red #40, corn syrup, hydrogenated cottonseed oil, natural and artificial flavor, propylene glycol, sucrose
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.Use temporarily relieve: occational minor irritation, pain, sore mouth and sore throat
Purpose
Information about the drug product’s indications for use.Purpose Oral anesthetic/Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Bactimicina for Sore Throat Benzocaine FD&C RED NO. 40 PROPYLENE GLYCOL SUCROSE HYDROGENATED COTTONSEED OIL BENZOCAINE BENZOCAINE FD&C YELLOW NO. 6 DEXTROSE CORN SYRUP
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.Principle Display Fast Acting Trusted since 1978 New Look Maximum Strength Bactimicina ® Sore Throat Pain Relief Benzocain Oral Anesthetic Orange Flavor 18 Lozenges Bactimicina Lozenges
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 Fact
Distributed by De La Cruz Products A Division of DLC Laboratories, Inc. Paramount, CA 90723 USA
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for teething in children under 5 years of age
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 if more than used for pain relief is accidentally swallowed, get medical help or contact a Poison COntrol Center immediately
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Question 1-800-858-3889
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops
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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use
Storage and handling
Information about safe storage and handling of the drug product.Other information protect from moisture store at room temperature check expiration date before using
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 Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a 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. Stop use and seek immediate medical attention if you or a child in your care developes: pale, gray, or blue colored skin (cyanosis) shortness of breath headache dizziness or lightheadedness rapid heart rate 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 any other "caine" anesthetics. If skin reation occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. Do not use for teething in children under 5 years of age When using this product do not exceed recommended dosage Stop use and ask a 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 health professional before use Keep out of reach of children In case of overdose, or if more than used for pain relief is accidentally swallowed, get medical help or contact a Poison COntrol Center immediately
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