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  5. Label Information: Theracare Maximum Strength Oral Pain Relief Severe

FDA Label for Theracare Maximum Strength Oral Pain Relief Severe

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theracare Maximum Strength Oral Pain Relief Severe Product Label

The following document was submitted to the FDA by the labeler of this product Veridian Healthcare. 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



Benzocaine 20%

Benzalkonium Chloride 0.1%


Purpose



Oral pain reliever

Antiseptic


Use



  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

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 develops: ■ pale, gray or blue-colored skin (cyanosis) ■ headache ■ rapid heart rate ■ shortness of breath ■ dizziness or lightheadedness ■ 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 other "caine" anesthetics


Otc - Do Not Use



Do not use

  • more than directed
  • for more than 7 days unless directed by a physician or healthcare provider

Otc - Ask Doctor



Stop use and ask a physician if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days

Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN:

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away (1-800-222-1222)


Dosage & Administration



Directions

  • Adults and children 2 years of age and over - Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
  • Children under 12 years of age - Should be supervised in the use of this product
  • Children under 2 years of age - Ask a physician or healthcare provider

Other Information



  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
  • do not use if tube seal under cap is broken
  • store at 20-25C (68-77F)

Inactive Ingredients



Glycerin, polyethylene glycol, saccharin sodium, sodium polyacrylate, sorbic acid, sorbitol, strawberry furanone, water.


Questions Or Comments?



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