FDA Label for Rite Aid Maximum Toothache Reliever
View Indications, Usage & Precautions
Rite Aid Maximum Toothache Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Rite Aid. 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.
Other
Drug Facts
DISTRIBUTED BY:
RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
TAMPER EVIDENT: Do not use if tube tip is cut prior to use
Otc - Active Ingredient
Active ingredient
Benzocaine 20%
Menthol 0.26%
Otc - Purpose
Purpose
Oral Pain Reliever
Oral Pain Reliever
Indications & Usage
Use
- for the temporary relief of pain due to toothaches
- to help protect against infection of minor oral irritation
Warnings
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 told to do so by a dentist or doctor
- for teething
- in children under 2 years of age
Otc - Stop Use
Stop use and ask a doctor if
- swelling, rash or fever develops
- irritation, pain or redness persists or worsens
- symptoms do not improve in 7 days
- allergic reaction occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- cut open tip of tube on score mark
- do not use if tip is cut prior to opening
- adults and children 2 years of age and older: apply to affected area up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in the use of this product
- children under 2 years of age: do not use
Other Safety Information
Other information
- do not use if tip is cut prior to opening
- this preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted
- do not use continuously
- this formula will stay in place for extended duration of relief
- avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
Inactive Ingredient
Inactive ingredientsAmmonium Glycyrrhizate, Flavor, Polyethylene Glycol, Sodium Saccharin, Sorbic Acid
Package Label.Principal Display Panel
RITE AID® PHARMACY
MAXIMUM toothache reliever
immediate relief of toothache pain
Fast acting GEL
ORAL PAIN RELIEVER
Double Medicated
- 20% Benzocaine for toothache pain relief
- Menthol to sooth gums
NET WT 0.42 OZ (12 g)
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