Medical Information and Disclosures

Approved Uses
BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to
temporarily improve the look of both moderate to severe crow’s feet lines and frown lines
between the eyebrows in adults.
BOTOX® Cosmetic may cause serious side effects that can be life threatening. Get
medical help right away if you have any of these problems any time (hours to weeks)
after injection of BOTOX® Cosmetic:
 Problems swallowing, speaking, or breathing, due to weakening of associated muscles,
can be severe and result in loss of life. You are at the highest risk if these problems are preexisting
before injection. Swallowing problems may last for several months
 Spread of toxin effects. The effect of botulinum toxin may affect areas away from the
injection site and cause serious symptoms including: loss of strength and all-over muscle
weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss
of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble
BOTOX® Cosmetic dosing units are not the same as, or comparable to, any other
botulinum toxin product.
There has not been a confirmed serious case of spread of toxin effect when
BOTOX® Cosmetic has been used at the recommended dose to treat frown lines, crow’s
feet lines, or both at the same time.
BOTOX® Cosmetic may cause loss of strength or general muscle weakness, vision
problems, or dizziness within hours to weeks of taking BOTOX® Cosmetic. If this happens,
do not drive a car, operate machinery, or do other dangerous activities.
Serious and/or immediate allergic reactions have been reported. They include: itching,
rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical
help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.
Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in
BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other
botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport®
(abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned
injection site.
Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s
disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of
serious side effects including difficulty swallowing and difficulty breathing from typical doses of
BOTOX® Cosmetic.
Tell your doctor about all your medical conditions, including: plans to have surgery; had
surgery on your face; weakness of forehead muscles: trouble raising your eyebrows; drooping
eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not
known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not
known if BOTOX® Cosmetic passes into breast milk).
Tell your doctor about all the medicines you take, including prescription and
nonprescription medicines, vitamins, and herbal products. Using BOTOX® Cosmetic with
certain other medicines may cause serious side effects. Do not start any new medicines
until you have told your doctor that you have received BOTOX® Cosmetic in the past.
Tell your doctor if you have received any other botulinum toxin product in the last 4 months;
have received injections of botulinum toxin such as Myobloc®, Dysport®, or Xeomin®
in the past (tell your doctor exactly which product you received); have recently received an
antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep
medicine; take aspirin-like products or blood thinners.
Other side effects of BOTOX® Cosmetic include: discomfort or pain at the injection site;
headache; and eye problems: double vision, blurred vision, drooping eyelids, and swelling of
your eyelids.
For more information refer to the Medication Guide or talk with your doctor.
To report a side effect, please call Allergan at 1-800-433-8871.
[Please see accompanying BOTOX® Cosmetic full Product Information including Boxed
Warning and Medication Guide.]


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