GLP-1 receptor agonists—including Ozempic®, Mounjaro®, Zepbound®, Wegovy®, Semaglutide, and Tirzepatide—have been prescribed (on-and-off label) for weight management, including obesity, along with a reduced caloric diet and increased physical activity. Ozempic® and Mounjaro® are FDA-approved for type 2 diabetes treatment, but may be prescribed off-label for weight loss at a healthcare provider’s discretion. Take precaution with, and read all warnings concerning, GLP-1s, as they may cause serious side effects, including a risk of thyroid c-cell tumors. Do not use if you or your family have a history of a type of thyroid cancer called MTC (medullary thyroid carcinoma) or MEN 2 (multiple endocrine neoplasia syndrome). See important warnings & safety info about these medications. As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a GLP-1 compounded drug that is effective when prescribed off label for weight loss, which is prepared by a state-licensed sterile compounding pharmacy partner. Although GLP-1 compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Thoroughly review all warnings and essential safety information regarding these drugs.
As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a compounded drug, which is prepared by a state-licensed sterile compounding pharmacy partner. Although compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of compounded semaglutide based on your medical evaluation. FDA-approved medicines containing semaglutide are available.
Semaglutide may cause serious side effects, including possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Semaglutide and medicines that work like Semaglutide caused thyroid tumors, including thyroid cancer. It is not known if Semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Semaglutide if:
Before using Semaglutide, tell your healthcare provider if you have any other medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Semaglutide may affect the way some medicines work and some medicines may affect the way Semaglutide works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Semaglutide slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
Semaglutide may cause serious side effects, including:
The most common side effects of Semaglutide may include:
Semaglutide is a prescription medication. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1800FDA1088.
This summary provides basic information about compounded semaglutide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded semaglutide and how to take it. Your healthcare provider is the best person to help you decide if compounded semaglutide is right for you.
Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions, and additional information.
Note: The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
WARNING: RISK OF THYROID C-CELL TUMORS
As an alternative to FDA-approved branded products, where appropriate, a provider may prescribe a compounded drug, which is prepared by a state-licensed sterile compounding pharmacy partner. Although compounded drugs are permitted to be prescribed under federal law, they are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of compounded Tirzepatide based on your medical evaluation. FDA-approved medicines containing Tirzepatide are available.
Tirzepatide may cause serious side effects, including possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats, Tirzepatide and medicines that work like Tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if Tirzepatide will cause thyroid tumors, or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Tirzepatide if:
Many people experience no side effects. Some of the most common or potential side effects of Tirzepatide include:
These are not all the possible side effects of Tirzepatide. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.
As with other medications, compounded Tirzepatide can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Tirzepatide delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Tirzepatide , please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e., warfarin) should be monitored closely while on Tirzepatide .
This summary provides basic information about compounded Tirzepatide but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about compounded Tirzepatide and how to take it. Your healthcare provider is the best person to help you decide if compounded Tirzepatide is right for you.
Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions, and additional information.
You are encouraged to report negative side effects of compounded semaglutide to the FDA. Visit https://www.fda.gov/medwatch or call 1800FDA1088. In case of emergencies, please call 911 or go to the nearest emergency room.
Note : The above statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
GLP-1s are contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take them if you have ever had thyroid cancer. In studies with rodents, GLP-1s caused thyroid tumors, including thyroid cancer; it is not known if they will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.
Tell your healthcare provider about your medical history prior to taking Ozempic®. Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Ozempic®;, as your diabetes medications may need to be adjusted as you lose weight.
Use adequate contraception while taking this medication. Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.
Notify your doctor if you have kidney, liver, or pancreas problems. Stop using Ozempic® and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting. Stop using Ozempic® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Ozempic® if suspected and promptly seek medical advice.
WARNING
Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:
Note: Never share the Ozempic® pen with other people.
Many people experience no side effects. Some of the most common or potential side effects include:
These symptoms often subside as your body adjusts to the medications. Please notify your provider if side effects persist. For a complete list of side effects, review the medication packaging inserts.
As with other medications, Ozempic® can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Ozempic® delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Ozempic®, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e. warfarin) should be monitored closely while on Ozempic®.
Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions, and additional information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1800FDA1088. In case of emergencies, please call 911 or go to the nearest emergency room.
This information is not comprehensive. Please see the full Prescribing Information and Medication Guide for complete safety information for Ozempic®.
GLP-1s are contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take them if you have ever had thyroid cancer. In studies with rodents, GLP-1s caused thyroid tumors, including thyroid cancer; it is not known if they will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.
If you experience a medical emergency, call 911 or go to the nearest emergency room.
Tell your healthcare provider about your medical history prior to taking Mounjaro®.
Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Mounjaro®, as your diabetes medications may need to be adjusted as you lose weight.
Females of reproductive potential should use adequate contraception while taking this medication. It is advised to use a non-oral contraceptive method (instead of oral contraceptive) or, if using oral contraception- add a barrier method of contraception 4 weeks after initiation and 4 weeks after dose escalation.
Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.
Notify your doctor if you have kidney, liver, or pancreas problems.
Stop using Mounjaro® and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.
Stop using Mounjaro® and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Mounjaro® if suspected and promptly seek medical advice.
WARNING
Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:
Note: Never share the Mounjaro® pen with other people.
These symptoms often subside as your body adjusts to the medications. Please notify your provider if side effects persist. For a complete list of side effects, review the medication packaging inserts.
As with other medications, Mounjaro® can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Mounjaro® delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Mounjaro®, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (i.e. warfarin) should be monitored closely while on Mounjaro®.
This summary provides basic information about Mounjaro® but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro® and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro® is right for you.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1800FDA1088. In case of emergencies, please call 911 or go to the nearest emergency room.
Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.
This information is not comprehensive. Please see the full Prescribing Information, Instructions for Use and Medication Guide for complete safety information for Mounjaro®.
In rats, tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C- cell tumors at clinically relevant exposures. It is unknown whether Zepbound causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined.
Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of Zepbound and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Zepbound.
INDICATION
Zepbound® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
Limitations of Use:
CONTRAINDICATIONS
Zepbound is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2, and in patients with known serious hypersensitivity to tirzepatide or any of the excipients in Zepbound. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with tirzepatide.
Risk of Thyroid C-cell Tumors
Counsel patients regarding the potential risk for MTC with the use of Zepbound and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with Zepbound. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.
Severe Gastrointestinal Disease
Use of Zepbound has been associated with gastrointestinal adverse reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients receiving Zepbound (5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1%) than placebo (1.0%). Zepbound has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Acute Kidney Injury
Use of Zepbound has been associated with acute kidney injury, which can result from dehydration due to gastrointestinal adverse reactions to Zepbound, including nausea, vomiting, and diarrhea. In patients treated with GLP-1 receptor agonists, there have been post-marketing reports of acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis. Some of these events have been reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration. Monitor renal function in patients reporting adverse reactions to Zepbound that could lead to volume depletion.
Acute Gallbladder Disease
Treatment with Zepbound and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In clinical trials of Zepbound, cholelithiasis was reported in 1.1% of Zepbound-treated patients and 1.0% of placebo-treated patients, cholecystitis was reported in 0.7% of Zepbound-treated patients and 0.2% of placebo- treated patients, and cholecystectomy was reported in 0.2% of Zepbound-treated patients and no placebo-treated patients. Acute gallbladder events were associated with weight reduction. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.
Acute Pancreatitis
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists or tirzepatide. In clinical trials of tirzepatide for a different indication, 14 events of acute pancreatitis were confirmed by adjudication in 13 tirzepatide-treated patients (0.23 patients per 100 years of exposure) versus 3 events in 3 comparator-treated patients (0.11 patients per 100 years of exposure). In Zepbound clinical trials, 0.2% of Zepbound-treated patients had acute pancreatitis confirmed by adjudication (0.14 patients per 100 years of exposure) versus 0.2% of placebo-treated patients (0.15 patients per 100 years of exposure). Zepbound has not been studied in patients with a prior history of pancreatitis. It is unknown if patients with a history of pancreatitis are at higher risk for development of pancreatitis on Zepbound. Observe patients for signs and symptoms of pancreatitis, including persistent severe abdominal pain sometimes radiating to the back, which may or may not be accompanied by vomiting. If pancreatitis is suspected, discontinue Zepbound and initiate appropriate management. If the diagnosis of pancreatitis is confirmed, Zepbound should not be restarted.
Hypersensitivity Reactions
There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) in patients treated with tirzepatide. In Zepbound clinical trials, 0.1% of Zepbound-treated patients had severe hypersensitivity reactions compared to no placebo-treated patients. If hypersensitivity reactions occur, advise patients to promptly seek medical attention and discontinue use of Zepbound. Do not use in patients with a previous serious hypersensitivity reaction to tirzepatide or any of the excipients in Zepbound. Use caution in patients with a history of angioedema or anaphylaxis with a GLP- 1 receptor agonist because it is unknown if such patients will be predisposed to these reactions with Zepbound.
Hypoglycemia
Zepbound lowers blood glucose and can cause hypoglycemia. In a trial of patients with type 2 diabetes mellitus and BMI ≥27 kg/m2, hypoglycemia (plasma glucose ≶54 mg/dL) was reported in 4.2% of Zepbound-treated patients versus 1.3% of placebo-treated patients. In this trial, patients taking Zepbound in combination with an insulin secretagogue (e.g., sulfonylurea) had increased risk of hypoglycemia (10.3%) compared to Zepbound-treated patients not taking a sulfonylurea (2.1%). Hypoglycemia has also been associated with Zepbound and GLP-1 receptor agonists in adults without type 2 diabetes mellitus. There is also increased risk of hypoglycemia in patients treated with tirzepatide in combination with insulin. Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes mellitus, monitor blood glucose prior to starting Zepbound and during Zepbound treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogue) or insulin.
Diabetic Retinopathy Complications in Patients with Type 2 Diabetes Mellitus
Rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy. Tirzepatide has not been studied in patients with non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema. Patients with a history of diabetic retinopathy should be monitored for progression of diabetic retinopathy.
Suicidal Behavior and Ideation
Suicidal behavior and ideation have been reported in clinical trials with other chronic weight-management products. Monitor patients treated with Zepbound for the emergence or worsening of depression, suicidal thoughts or behaviors, and/or any unusual changes in mood or behavior. Discontinue Zepbound in patients who experience suicidal thoughts or behaviors. Avoid Zepbound in patients with a history of suicidal attempts or active suicidal ideation.
Most common adverse reactions
The most common adverse reactions, reported in ≥5% of patients treated with Zepbound are: nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.
Drug Interactions
Zepbound lowers blood glucose. When initiating Zepbound, consider reducing the dose of concomitantly administered insulin secretagogues (e.g., sulfonylureas) or insulin to reduce the risk of hypoglycemia. Zepbound delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Caution should be exercised when oral medications are concomitantly administered with Zepbound. Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered with Zepbound.
Pregnancy
Advise pregnant patients that weight loss is not recommended during pregnancy and to discontinue Zepbound when a pregnancy is recognized. Available data with tirzepatide in pregnant patients are insufficient to evaluate for a drug-related risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Based on animal reproduction studies, there may be risks to the fetus from exposure to tirzepatide during pregnancy. There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Zepbound (tirzepatide) during pregnancy. Pregnant patients exposed to Zepbound and healthcare providers are encouraged to contact Eli Lilly and Company at 1- 800-LillyRx (1-800-545-5979).
Lactation
There are no data on the presence of tirzepatide or its metabolites in animal or human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Zepbound and any potential adverse effects on the breastfed infant from Zepbound or from the underlying maternal condition.
Females and Males of Reproductive Potential
Use of Zepbound may reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying. This delay is largest after the first dose and diminishes over time. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception, for 4 weeks after initiation with Zepbound and for 4 weeks after each dose escalation.
Pediatric Use
The safety and effectiveness of Zepbound have not been established in pediatric patients less than 18 years of age.
Please see accompanying Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide.
Please see Instructions for Use.
BLACK BOX WARNING:
In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined.
WEGOVY® is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of WEGOVY® and inform them of symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with WEGOVY®.
What is the most important information I should know about Wegovy®?
Wegovy® may cause serious side effects, including:
Do not use Wegovy® if:
Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin.
Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.
What are the possible side effects of Wegovy®?
Wegovy® may cause serious side effects, including:
The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.
Please see Prescribing Information and Medication Guide for Wegovy®.
RYBELSUS® (semaglutide) tablets 7 mg or 14 mg is a prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.
What is the most important information I should know about RYBELSUS®?
RYBELSUS® may cause serious side effects, including:
Do not use RYBELSUS® if:
Before using RYBELSUS®, tell your healthcare provider if you have any other medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RYBELSUS® may affect the way some medicines work and some medicines may affect the way RYBELSUS® works.
How should I take RYBELSUS®?
What are the possible side effects of RYBELSUS®?
RYBELSUS® may cause serious side effects, including:
The most common side effects of RYBELSUS® may include nausea, stomach (abdominal) pain, diarrhea, decreased appetite, vomiting, and constipation. Nausea, vomiting, and diarrhea are most common when you first start RYBELSUS®.
Please see Prescribing Information and Medication Guide for RYBELSUS®.
RYBELSUS® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatchopens or call 1-800-FDA-1088.
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