BOTOX (onabotulinumtoxin A) 100iu Single Use Vial

BOTOX® Cosmetic
(onabotulinumtoxinA)
for injection Manufactured by: Allergan Pharmaceuticals

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MEDICATION GUIDE
BOTOX®
BOTOX® Cosmetic
(Boe-tox) (onabotulinumtoxinA) for Injection

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BOTOX^® Cosmetic is a simple, non-surgical procedure for temporarily reducing the appearance of moderate to severe glabellar lines - the vertical frown lines between the eyebrows that look like an "11" - in adult women and men aged 18 to 65. BOTOX^® Cosmetic reduces the activity of the muscles that cause the "11s" to form by blocking nerve impulses that trigger wrinkle-causing muscle contractions, creating an improved appearance between the brows. Results can last up to four months and may vary with each patient. Ask your doctor if BOTOX^® Cosmetic is right for you.

Indication

BOTOX^® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary).

IMPORTANT SAFETY INFORMATION

BOTOX^® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or 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 pre-existing 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 (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing.

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.

The dose of BOTOX^® Cosmetic is not the same as, or comparable to, another botulinum toxin product.

Serious and or immediate allergic reactions have been reported. These reactions include itchy rash, swelling, and shortness of breath. Tell your doctor or get medical help right away if you experience any such symptoms, further injection of BOTOX^® Cosmetic should be discontinued.

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^® or Dysport^®; have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis or Lambert-Eaton syndrome as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX^® Cosmetic.

Tell your doctor about all your medical conditions, including if you have: plans to have surgery; had surgery on your face; weakness of forehead muscles, such as 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 breastfeed (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.

BOTOX^® Cosmetic may cause loss of strength or general muscle weakness, or vision problems. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Other side effects of BOTOX^® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

For more information refer to the Medication Guide or talk with your doctor.

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What is Botox?

Botox (onabotulinumtoxinA) is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Botox is used to treat cervical dystonia (severe spasms in the neck muscles), upper limb spasticity in adults and severe underarm sweating (hyperhidrosis).

Botox is also used to treat certain eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

Botox is also used to temporarily lessen the appearance of facial wrinkles.

Botox may also be used for other purposes not listed in this medication guide

Botox injection is manufactured by Allergan. This product comes in two product sizes: Botox 100IU and 50IU. however we only offer the Botox in 100IU's. In some countries Botox is also marketed under the name Vistabel. The product that is supplied is with predominantly English language packaging.

Important information about Botox

Distant Spread of Toxin Effect:
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection.

Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses.

DESCRIPTION

BOTOX® Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose, and yeast extract, intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. One Unit of BOTOX® Cosmetic corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. The method utilized for performing the assay is specific to Allergan’s product BOTOX® Cosmetic. Due to specific details of this assay such as the vehicle, dilution
scheme and laboratory protocols for the various mouse LD50 assays, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. In addition, differences in species sensitivities to different botulinum neurotoxin serotypes precludes extrapolation of animal-dose activity relationships to human dose estimates. The specific activity of BOTOX®  Cosmetic is approximately 20 Units/nanogram of neurotoxin protein complex.

Each vial of BOTOX®
Cosmetic contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride or 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.

INDICATIONS AND USAGE

BOTOX® Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients < 65 years of age.

CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

WARNINGS
BOTOX® and BOTOX® Cosmetic contain the same active ingredient in the same formulation. Therefore, adverse events observed with the use of BOTOX® also have the potential to be associated with the use of BOTOX® Cosmetic. The recommended dosage and frequency of administration for BOTOX® Cosmetic should not be exceeded. Risks resulting from administration at higher dosages are not known.

The botulinum toxin contained in Botox can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulism toxin injections, even for cosmetic purposes.

Call your doctor at once if you have drooping eyelids, vision problems, severe muscle weakness, loss of bladder control, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a Botox injection. Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes. Do not seek Botox injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection.

Using Botox more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive Botox if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

Before receiving a Botox injection, tell your doctor if you have ALS ( Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, or heart disease.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

Before receiving Botox

You should not receive Botox if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely receive Botox.

• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

• myasthenia gravis;

• Lambert-Eaton syndrome; or

• heart disease.

Botox is made using human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. It is not known whether Botox is harmful to an unborn baby. Before you receive Botox, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether botulinum toxin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.

How is Botox given?

Botox is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give you this injection.

Botox injections should be given only by a trained medical professional, even when used for cosmetic purposes.

Your botulinum toxin injection may be given into more than one area at a time, depending on the condition being treated.

While receiving Botox injections for an eye muscle conditions, you may need to use eye drops, ointment, a special contact lens or other device to protect the surface of your eye. Follow your doctor's instructions.

If you are being treated for excessive sweating, shave your underarms about 24 hours before you will receive your injection. Do not apply underarm antiperspirants or deodorants for 24 hours before you receive the Botox injection. Avoid exercise and hot foods or beverages within 30 minutes before the injection.

It may take up to 2 weeks after injection before neck muscle spasm symptoms begin to improve. You may notice the greatest improvement at 6 weeks after injection.

It may take only 1 to 3 days after injection before eye muscle spasm symptoms begin to improve. You may notice the greatest improvement at 2 to 6 weeks after injection.

The effects of a Botox injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin. Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last Botox injection.

Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

What happens if I miss a dose?

Since Botox has a temporary effect and is given at widely spaced intervals, missing a dose is not likely to be harmful.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include muscle weakness, trouble swallowing, and weak or shallow breathing.

What should I avoid after receiving Botox?

Avoid using underarm antiperspirants or deodorants for 24 hours after an injection if you are being treated for excessive underarm sweating.

Avoid going back to your normal physical activities too quickly after receiving a botulinum toxin injection.

Botox is used for:Reducing the severity of abnormal head position and neck pain associated with neck problems. It may be used to reduce armpit sweating that does not respond to treatment with other medicines. It may also be used to treat certain focusing problems and eye spasms, as well as other conditions as determined by your doctor.Botox is a neurotoxin. It works by blocking nerve impulses to the muscles or sweat glands, temporarily paralyzing the muscle or gland.

Products Similar

There are also several other products that are similar to Botox, that are also based on botulinum toxin. In the same manner that you can get Botox online, you can also purchase Dysport, which is also known as Reloxin.

ADVERSE REACTIONS
General
BOTOX® and BOTOX® Cosmetic contain the same active ingredient in the same formulation. Therefore adverse events observed with the use of BOTOX® also have the potential to be associated with the use of BOTOX® Cosmetic. The most serious adverse events reported after treatment with botulinum toxin include spontaneous reports of death, sometimes associated with anaphylaxis, dysphagia, pneumonia, and/or other significant debility.

DOSAGE AND ADMINISTRATION
For Intramuscular Injection Only
BOTOX®Cosmetic is to be reconstituted only with 0.9% sterile, non-preserved saline prior to intramuscular injection. Per the dilution table below, draw up the required amount of 0.9% sterile non-preserved sodium chloride solution into a syringe to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL and a total treatment dose of 20 Units in 0.5 mL. The duration of activity of BOTOX®Cosmetic for glabellar lines is approximately 3-4 months. The safety and effectiveness of more frequent dosing with BOTOX®Cosmetic has not been clinically evaluated and is not recommended.

Dilution Table

• Diluent Added to 100 Unit Vial (0.9% Sodium Chloride Injection Only)
  
• 2.5 mL.

• Resulting Dose Units per 0.1 mL
• 4 Units

• Diluent Added to 50 Unit Vial (0.9% Sodium Chloride Injection Only)
• 1.25 mL

• Resulting Dose Units per 0.1 mL
• 4 Units

• Reconstituted BOTOX® Cosmetic should be clear, colorless, and free of particulate matter.

BOTOX® Cosmetic is supplied as a single use vial. The product and diluent do not contain a preservative. Once opened and reconstituted it should be stored in a refrigerator (2° to 8°C) and used within 24 hours. Discard any remaining solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever
solution and container permit. Do not freeze reconstituted BOTOX® Cosmetic.

Dilution Technique
Using a 21-gauge needle and an appropriately sized syringe draw up a total of 2.5 mL/100 Unit vial or 1.25 mL/50 Unit vial of 0.9% sterile saline without a preservative. Insert the needle at a 45° angle and slowly inject into the BOTOX® Cosmetic vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently rotate the vial and record the date and time of
reconstitution on the space on the label.

Draw at least 0.5 mL of the properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe and expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle.

Injection Technique
Glabellar facial lines arise from the activity of the corrugator and orbicularis oculi muscles. These muscles move the brow medially, and the procerus and depressor supercilii pull the brow inferiorly. This creates a frown or “furrowed brow”. The location, size, and use of the muscles vary markedly among individuals. Lines induced by facial expression occur perpendicular to the direction of action of contracting facial muscles. An effective dose for facial lines is determined by gross observation of the patient’s ability to activate the superficial muscles injected.

In order to reduce the complication of ptosis the following steps should be taken:

• Avoid injection near the levator palpebrae superioris, particularly in patients with larger
brow depressor complexes.
• Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital
ridge.
• Ensure the injected volume/dose is accurate and where feasible kept to a minimum.
• Do not inject toxin closer than 1 cm above the central eyebrow.

Using a 30-33 gauge needle, inject a dose of 0.1 mL into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units. Typically the initial doses of reconstituted BOTOX® Cosmetic induce chemical denervation of the injected muscles one to two days after injection, increasing in intensity during the first week.

HOW SUPPLIED
BOTOX® Cosmetic is supplied in a single use vial in the following sizes:

• 50 Units: NDC 0023-3919-50
• 100 Units: NDC 0023-9232-01

Vials of BOTOX® Cosmetic have a holographic film on the vial label that contains the name “Allergan” within horizontal lines of rainbow color. In order to see the hologram, rotate the vial back and forth between your fingers under a desk lamp or fluorescent light source. (Note: the holographic film on the label is absent in the date/batch area.) If you do not see the lines of rainbow color or the name “Allergan,” do not use the product and contact Allergan for additional information.

Rx Only
Single use vial.

Storage
Unopened vials of BOTOX® Cosmetic should be stored in a refrigerator (2° to 8°C) for up to 36 months for the 100 Unit vial or up to 24 months for the 50 Unit vial.

Administer BOTOX® Cosmetic within 24 hours of reconstitution; during this period reconstituted BOTOX® Cosmetic should be stored in a refrigerator (2° to 8°C). Reconstituted BOTOX® Cosmetic should be clear, colorless and free of particulate matter.

Do not use after the expiration date on the vial. All vials, including expired vials, or equipment used with the drug should be disposed of carefully as is done with all medical waste.

© 2009 Allergan, Inc.
® mark owned by Allergan, Inc.
U.S. Patents 6,974,578; 6,683,049; and 6,896,886
Manufactured by: Allergan Pharmaceuticals Ireland
a subsidiary of: Allergan, Inc., 2525 Dupont Dr., Irvine, CA 92612

Read the Medication Guide that comes with BOTOX or BOTOX Cosmetic before you start using it and each time it is given to you. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. You should share this information with your family members and caregivers.

What is the most important information I should know about BOTOX and BOTOX Cosmetic?

BOTOX and BOTOX Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems after treatment with BOTOX or BOTOX Cosmetic:

•Problems swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of BOTOX or BOTOX Cosmetic usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with BOTOX or BOTOX Cosmetic.

•People with certain breathing problems may need to use muscles in their neck to help them breathe. These patients may be at greater risk for serious breathing problems with BOTOX or BOTOX Cosmetic.

•Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving BOTOX or BOTOX Cosmetic have the highest risk of getting these problems.

•Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include:

•loss of strength and muscle weakness all over the body
•double vision
•blurred vision and drooping eyelids
•hoarseness or change or loss of voice (dysphonia)
•trouble saying words clearly (dysarthria)
•loss of bladder control
•trouble breathing
•trouble swallowing

These symptoms can happen hours to weeks after you receive an injection of BOTOX or BOTOX Cosmetic. These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while receiving BOTOX or BOTOX Cosmetic?"

There has not been a confirmed serious case of spread of toxin effect away from the injection site when BOTOX has been used at the recommended dose to treat severe underarm sweating, blepharospasm, or strabismus, or when BOTOX Cosmetic has been used at the recommended dose to treat frown lines.

What are BOTOX and BOTOX Cosmetic?
BOTOX is a prescription medicine that is injected into muscles and used:

•to treat increased muscle stiffness in elbow, wrist, and finger muscles in adults with upper limb spasticity.
•to treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults.
•to treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years and older.

BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough.

BOTOX Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary). It is not known whether BOTOX is safe or effective in children younger than:

•18 years of age for treatment of spasticity
•16 years of age for treatment of cervical dystonia
•18 years of age for treatment of hyperhidrosis
•12 years of age for treatment of strabismus or blepharospasm

BOTOX Cosmetic is not recommended for use in children younger than 18 years of age.
It is not known whether BOTOX and BOTOX Cosmetic are safe or effective for other types of muscle spasms or for severe sweating anywhere other than your armpits.

Who should not take BOTOX or BOTOX Cosmetic?
Do not take BOTOX or BOTOX Cosmetic if you:

•are allergic to any of the ingredients in BOTOX or BOTOX Cosmetic. See the end of this Medication Guide for a list of ingredients in BOTOX and BOTOX Cosmetic.
•had an allergic reaction to any other botulinum toxin product such as Myobloc® or Dysport™
•have a skin infection at the planned injection site

What should I tell my doctor before taking BOTOX or BOTOX Cosmetic?
Tell your doctor about all your medical conditions, including if you have:

•a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome). See "What is the most important information I should know about BOTOX and BOTOX Cosmetic?"
•allergies to any botulinum toxin product
•had any side effect from any botulinum toxin product in the past
•a breathing problem, such as asthma or emphysema
•swallowing problems
•bleeding problems
•plans to have surgery
•had surgery on your face
•weakness of your forehead muscles, such as trouble raising your eyebrows
•drooping eyelids
•any other change in the way your face normally looks
•are pregnant or plan to become pregnant. It is not known if BOTOX or BOTOX Cosmetic can harm your unborn baby.
•are breast-feeding or plan to breastfeed. It is not known if BOTOX or 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 or 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 or BOTOX Cosmetic in the past. Especially tell your doctor if you:

•have received any other botulinum toxin product in the last four months
•have received injections of botulinum toxin, such as Myobloc® (rimabotulinumtoxinB) or Dysport™ (abobotulinumtoxinA) in the past. Be sure your doctor knows 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

Ask your doctor if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take BOTOX or BOTOX Cosmetic?

•BOTOX or BOTOX® Cosmetic is an injection that your doctor will give you.
•BOTOX is injected into your affected muscles or skin.
•BOTOX Cosmetic is injected into your affected muscles.

Your doctor may change your dose of BOTOX or BOTOX Cosmetic, until you and your doctor find the best dose for you.

What should I avoid while taking BOTOX or BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic may cause loss of strength or general muscle weakness, or vision problems within hours to weeks of taking BOTOX or BOTOX Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.  See "What is the most important information I should know about BOTOX and BOTOX Cosmetic?"

What are the possible side effects of BOTOX and BOTOX Cosmetic?
BOTOX and BOTOX Cosmetic can cause serious side effects. Other side effects of BOTOX and BOTOX Cosmetic include:

•dry mouth
•discomfort or pain at the injection site
•tiredness
•headache
•neck pain
•eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.
•allergic reactions. Symptoms of an allergic reaction to BOTOX or BOTOX Cosmetic may include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of BOTOX and BOTOX Cosmetic. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.