FDA records indicate that there are no current recalls for this drug.
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Orajel Instant Relief For Teething Pain Recall
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Questions & Answers
Side Effects & Adverse Reactions
Warnings
Allergy Alert: do not use this product if our child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics
Do not use more than directed, for more than 7 days unless told to do so by a physician or healthcare provider
When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms persist, consult your physician.
Stop use and ask a physician if sore mouth symptoms do not improve in 7 days; irritation, pain or redness does not go away; swelling, rash or fever develops
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For the temporary relief of sore gums due to teething in children 2 years of age and older. For use in children under the age of 2, consult a physician or healthcare provider.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Orajel Instant Relief For Teething Pain Manufacturers
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Church & Dwight Co., Inc.
Orajel Instant Relief For Teething Pain | Church & Dwight Co., Inc.
Directions hold swab with solid white tip down bend and snap open swab tip at the colored rings. Throw away the broken off end before use. Wait 30-40 seconds for product to flow down into swab tip apply to the affected area up to 4 times daily or as directed by a physician or healthcare provider for infants under 2 years of age,consult a physician or healthcare provider
Other information do not use if label seal is broken prior to purchase, or if colored rings on tip of swab are not pink
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