FDA Label for Bactimicina For Sore Throat
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH LOZENGE)
- PURPOSE
- USE
- METHEMOGLOBINEMIA WARNING:
- ALLERGY ALERT
- SORE THROAT WARNING:
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTION
- OTHER
- PRINCIPLE DISPLAY
Bactimicina For Sore Throat Product Label
The following document was submitted to the FDA by the labeler of this product Dlc Laboratories, 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
Use
temporarily relieve:
- occational minor irritation, pain, sore mouth and sore throat
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
Directions
- adults and children 5 years of age and older:
- children under 5 years of age: do not use.
Dissolve 1 lozenge slowly in the mouth. May be repeated every 2 hours as needed or as directed by a doctor or dentist.
Other Information
- protect from moisture
- store at room temperature
- check expiration date before using
Inactive Ingredients
dextrose, FD&C yellow #6, FD&C red #40, corn syrup, hydrogenated cottonseed oil, natural and artificial flavor, propylene glycol, sucrose
Question
1-800-858-3889
Other
Distributed by
De La Cruz Products
A Division of DLC Laboratories, Inc.
Paramount, CA 90723 USA
Principle Display
Fast Acting
Trusted since 1978
New Look
Maximum Strength
Bactimicina ®
Sore Throat Pain Relief
Benzocain Oral Anesthetic
Orange Flavor
18 Lozenges
* Please review the disclaimer below.