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Drug Safety Information

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Compounded Semaglutide Injectable

About Your Prescription Medication
Written details about this medication are provided for your reference. Please review this information carefully before using the medication. If you have any questions, a licensed pharmacist is available during normal business hours to assist you.

FDA Warning
Do not take semaglutide if you have a condition known as Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2) or if you or a family member have a history of medullary thyroid cancer. In animal studies, this drug has been linked to thyroid C‑cell tumors, although it is unclear whether the same risk applies to humans. Seek immediate medical attention or contact your healthcare provider if you notice a lump in your neck, persistent hoarseness, trouble swallowing, or difficulty breathing.

This medication is a compounded prescription and has not been evaluated or approved by the FDA. As a result, the FDA does not review compounded medications for safety, quality, or effectiveness.

Key Information

  • This medication is intended only for the individual named on the prescription label.
  • Semaglutide should not be used during pregnancy, while planning pregnancy, or while breastfeeding.

About Semaglutide

Compounded semaglutide is a GLP‑1 receptor agonist designed to help with weight management in eligible adults.

Common side effects may include nausea, vomiting, constipation, diarrhea, stomach pain, fatigue, headache, or redness/swelling at the injection site. Please contact your provider if you start experiencing these or other side effects.

In some cases, semaglutide may cause issues with the pancreas or gallbladder. Stop taking the medication and seek emergency care if you experience severe, ongoing abdominal pain (with or without vomiting). 

Directions for Use

  • Check your vial before each dose. Do not use it if the solution appears cloudy or contains particles.
  • Administer as a once‑weekly subcutaneous injection in the abdomen, thigh, or back of the arm. Rotate injection sites weekly.

How to Inject:

  1. Hold the syringe between your index and middle fingers, with your thumb on the plunger.
  2. Position it at a 90‑degree angle to your skin.
  3. Insert the needle fully and slowly press the plunger until all medication is injected.
  4. Remove the needle carefully and dispose of used pens in a sharps container. If you don’t have one, a sturdy plastic household container (like a laundry detergent bottle) may be used instead.
  5. Your provider may gradually increase your dose to help limit side effects. Always follow the dosage instructions on your prescription label.
  6. Withdraw full doses from a single vial. Do not combine medication from multiple vials.
  7. If your vial does not contain enough for a full dose, discard it and open a new one.
  8. The concentration may change with a new prescription—always verify that you are using the correct vial.

Storage

  • Keep refrigerated at 36°F to 46°F (2°C to 8°C) in the packaging provided by the pharmacy.
  • Protect from light and do not freeze.
  • After puncturing the vial, note the date of opening and discard any unused medication after 28 days.
  • Store out of reach of children.

Precautions

  • Semaglutide is under review for potential effects on mood, including suicidal thoughts or behaviors. Report any new or worsening depression, mood changes, or suicidal thoughts to your provider right away.
  • Do not use if allergic to any ingredients.
  • Avoid use use if you or a family member has a history of medullary thyroid cancer or MEN 2.
  • Do not use if pregnant, while planning pregnancy, or while breastfeeding.
  • Seek emergency care for severe abdominal pain, vomiting, or back pain.

Missed Dose

If you miss a dose, take it as soon as possible within 5 days.
If more than 5 days have passed, skip the missed dose and continue with your regular schedule. Do not take an extra dose to compensate.

Questions & Reporting Side Effects

If you have questions, contact your prescribing provider.

Adverse events can be reported through the FDA at www.fda.gov/medwatch or by calling 1‑800‑FDA‑1088.

© 2025 VitalCore Health. All rights reserved.

Compounded Semaglutide Sublingual

Compounded semaglutide, a Glucagon-like Peptide-1 (GLP-1) receptor agonist, has proven to be an effective option for managing Type 2 Diabetes and promoting weight loss. Traditionally available as weekly injections or as a daily oral tablet, Semaglutide can now be formulated in a sublingual form for those who prefer to avoid needles and improve absorption compared to tablets. Sublingual semaglutide is held under the tongue, where it is absorbed directly into the bloodstream.

How does it work?

  • Compounded semaglutide works by mimicking the GLP-1 hormone, which is primarily used in the treatment of Type 2 Diabetes. This helps manage blood sugar levels and encourages weight loss by making patients feel full longer, reducing food intake.
  • Our compounded semaglutide sublingual suspension utilizes SubMagna™ SL HMW base, cutting-edge vehicle that is tailored to enhance the delivery of a broad spectrum of drugs, especially those with high molecular weights. It is an anhydrous, self-emulsifying base that transforms into an emulsion upon contact with saliva. This unique feature significantly improves the solubility and dispersibility of Semaglutide under the tongue.

Benefits of compounded sublingual semaglutide:

  • Needle-free: No more injections, making it easier and less stressful for patients who fear needles.
  • Better absorption: Sublingual administration bypasses the digestive system, avoiding the low absorption rates of oral tablets.

Administration:

  1. Always follow the directions on your prescription label on how to take your medication.
  2. Must shake well prior to use.
  3. Place under the tongue: the longer the medication is held under the tongue, the better the absorption will be. Recommend 1-2 minutes before swallowing.
  4. Take first thing in the morning, 30 minutes before any other medications or food/beverage other than water.

Potential Side Effects:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
  • Severe dizziness or passing out, a fast heartbeat, change in eyesight.
  • Low blood sugar can happen. The chance may be raised when this drug is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Contact your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
  • Severe and sometimes deadly pancreas problems (pancreatitis) have happened with this drug. Contact your doctor right away if you have severe stomach pain, severe back pain, or severe upset stomach or throwing up.
  • Severe side effects are rare, but may occur.
  • If you experience a severe side effect while taking this medication, please contact your physician immediately.
    • You may also report the side effects to the FDA Med-Watch Program at 1-800-FDA-1088.

Drug Interactions

One significant interaction to be aware of are medications that affect gastrointestinal motility, as Semaglutide slows gastric emptying. Concurrent use with other drugs that slow gastric emptying, such as opioids or anticholinergics, could enhance the effects and potentially lead to gastrointestinal adverse effects.

Storage

  • Semaglutide suspension should be stored at room temperature.
  • Compounded medications are not usually prepared in child resistant containers and should be kept away from children and pets. 
  • Unused medications left in the medicine cabinet can be a temptation for children and teenagers. Discard unused medications promptly. Do not flush drugs down the toilet or into the sink drain as they could be hazardous to the environment. Contact your local disposal company for more details about how to safely discard medications when they are expired or no longer needed. Big Red Barrel and Yellow Jug are national drug disposal programs. Visit www.bigredbarrel.com
  • Contamination may be present if the capsule is slightly damaged or cracked for liquids if a color change occurs or dark spots appear. If any of which are present, do not use and contact your provider immediately.

Expiration of your prescription & Beyond Use Date of the medication

  • Refer to the label for the expiration date of your “prescription.”
  • Your prescription expires in two ways:
  • One, you have used all the refills prescribed.
  • Two, the prescription has reached the expiration date of one year or six months for controlled drugs.
  • Allow plenty of time to visit your doctor and for the pharmacist to compound your prescription renewal.
  • Refer to the discard date or beyond use date on your bottle to learn when your “medication” should be discarded. Compounded medications have a shorter shelf life than those of manufactured drugs. The beyond use date is the longest date we can guarantee full potency of your medication.

Compounded Tirzepatide Injectable

About Your Medication
This handout provides important details about your prescription. Please review it carefully before using the medication. If you have questions, a licensed pharmacist is available during regular business hours to help.

FDA Warning
Do not use tirzepatide if you have been diagnosed with Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2) or if you or a family member has had medullary thyroid cancer. Studies in animals have shown an increased risk of thyroid C‑cell tumors, though it is unknown if this occurs in humans. If you develop a lump in your neck, persistent hoarseness, trouble swallowing, or difficulty breathing, contact your healthcare provider or seek immediate medical attention.

This medication is a compounded prescription and has not been evaluated or approved by the FDA. As a result, the FDA does not review compounded medications for safety, quality, or effectiveness.

Key Information

  • This medication is intended only for the individual named on the prescription label.
  • Tirzepatide should not be used during pregnancy, while planning pregnancy, or while breastfeeding.

About Tirzepatide

Tirzepatide is a dual GIP and GLP‑1 receptor agonist that helps improve blood sugar control in adults with type 2 diabetes and can also aid with weight loss in certain patients.

Possible side effects may include nausea, vomiting, diarrhea, constipation, stomach pain, fatigue, headache, heartburn, hair loss, burping, or redness/swelling at the injection site. Please contact your provider if you start experiencing these or other side effects.

Tirzepatide may also lead to problems with the pancreas or gallbladder. Stop taking the medication and get emergency medical care if you have severe abdominal pain that does not go away (with or without vomiting).

Directions for Use

  • Check your vial before each dose. Do not use it if the solution appears cloudy or contains particles.
  • Administer as a once‑weekly subcutaneous injection in the abdomen, thigh, or back of the arm. Rotate injection sites weekly.

How to Inject:

  1. Hold the syringe between your index and middle fingers, with your thumb on the plunger.
  2. Position it at a 90‑degree angle to your skin.
  3. Insert the needle fully and slowly press the plunger until all medication is injected.
  4. Remove the needle carefully and dispose of used pens in a sharps container. If you don’t have one, a sturdy plastic household container (like a laundry detergent bottle) may be used instead.
  5. Your provider may gradually increase your dose to help limit side effects. Always follow the dosage instructions on your prescription label.
  6. Withdraw full doses from a single vial. Do not combine medication from multiple vials.
  7. If your vial does not contain enough for a full dose, discard it and open a new one.
  8. The concentration may change with a new prescription—always verify that you are using the correct vial.

Storage

  • Keep refrigerated at 36°F to 46°F (2°C to 8°C) in the original packaging.
  • If needed, the pens may be kept at room temperature (up to 86°F / 30°C) for no more than 21 days.
  • Protect from light and freezing.
  • Keep out of reach of children.

Precautions

  • Tirzepatide is currently being evaluated for potential effects on mood and suicidal thoughts. Contact your provider right away if you notice worsening depression, mood changes, or suicidal thoughts. You can also call or text 988 for immediate support.
  • Do not take tirzepatide if you are allergic to any of its components.
  • Tirzepatide can reduce the effectiveness of oral contraceptives. Use another form of birth control for 4 weeks after starting treatment and for 4 weeks after each dose increase.

Missed Dose

If you miss a dose, take it as soon as possible within 4 days.
If more than 4 days have passed, skip the missed dose and continue with your regular schedule. Do not take an extra dose to compensate.

Questions & Reporting Side Effects

If you have questions, contact your prescribing provider.

Adverse events can be reported through the FDA at www.fda.gov/medwatch or by calling 1‑800‑FDA‑1088.

© 2025 VitalCore Health. All rights reserved.

Compounded Tirzepitide Sublingual

Compounded tirzepatide, a Glucagon-like Peptide-1 (GLP-1) receptor agonist and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist , has proven to be an effective option for managing Type 2 Diabetes and promoting weight loss. Traditionally available as weekly injections or as a daily oral tablet, Tirzepatide can now be formulated in a sublingual form for those who prefer to avoid needles and improve absorption compared to tablets. Sublingual Tirzepatide is held under the tongue, where it is absorbed directly into the bloodstream.

How does it work?

Tirzepatide works by mimicking the GLP-1 hormone and GIP, which is primarily used in the treatment of Type 2 Diabetes. This helps manage blood sugar levels and encourages weight loss by making patients feel full longer, reducing food intake.

Out compounded tirzepatide sublingual suspension utilizes SubMagna™ SL HMW base, cutting-edge vehicle that is tailored to enhance the delivery of a broad spectrum of drugs, especially those with high molecular weights. It is an anhydrous, self-emulsifying base that transforms into an emulsion upon contact with saliva. This unique feature significantly improves the solubility and dispersibility of Tirzepatide under the tongue.

Benefits of compounded sublingual tirzepatide:

  • Needle-free: No more injections, making it easier and less stressful for patients who fear needles.
  • Better absorption: Sublingual administration bypasses the digestive system, avoiding the low absorption rates of oral tablets.

Administration:

  1. Always follow the directions on your prescription label on how to take your medication.
  2. Must shake well prior to use.
  3. Place under the tongue: the longer the medication is held under the tongue, the better the absorption will be. Recommend 1-2 minutes before swallowing.
  4. Take first thing in the morning, 30 minutes before any other medications or food/beverage other than water.

Potential Side Effects:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of gallbladder problems like pain in the upper right belly area, right shoulder area, or between the shoulder blades; change in stools; dark urine or yellow skin or eyes; or fever with chills.
  • Severe dizziness or passing out, a fast heartbeat, change in eyesight.
  • Low blood sugar can happen. The chance may be raised when this drug is used with other drugs for diabetes. Signs may be dizziness, headache, feeling sleepy or weak, shaking, fast heartbeat, confusion, hunger, or sweating. Contact your doctor right away if you have any of these signs. Follow what you have been told to do for low blood sugar. This may include taking glucose tablets, liquid glucose, or some fruit juices.
  • Severe and sometimes deadly pancreas problems (pancreatitis) have happened with this drug. Contact your doctor right away if you have severe stomach pain, severe back pain, or severe upset stomach or throwing up.
  • Severe side effects are rare, but may occur. If you experience a severe side effect while taking this medication, please contact your physician immediately.
    • You may also report the side effect to the FDA MedWatch Program at 1-800-FDA-1088.

Drug Interactions

One significant interaction to be aware of are medications that affect gastrointestinal motility, as compounded tirzepatide slows gastric emptying. Concurrent use with other drugs that slow gastric emptying, such as opioids or anticholinergics, could enhance the effects and potentially lead to gastrointestinal adverse effects.

Storage

  • Tirzepatide suspension should be stored at room temperature.
  • Compounded medications are not usually prepared in child resistant containers and should be kept away from children and pets. 
  • Unused medications left in the medicine cabinet can be a temptation for children and teenagers. Discard unused medications promptly. Do not flush drugs down the toilet or into the sink drain as they could be hazardous to the environment. Contact your local disposal company for more details about how to safely discard medications when they are expired or no longer needed. Big Red Barrel and Yellow Jug are national drug disposal programs. Visit www.bigredbarrel.com
  • Contamination may be present if the capsule is slightly damaged or cracked for liquids if a color change occurs or dark spots appear. If any of which are present, do not use and contact your provider immediately.

Expiration of your prescription & Beyond Use Date of the medication

  • Refer to the label for the expiration date of your “prescription.”
  • Your prescription expires in two ways:
    • One, you have used all the refills prescribed.
    • Two, the prescription has reached the expiration date of one year or six months for controlled drugs.
  • Allow plenty of time to visit your doctor and for the pharmacist to compound your prescription renewal.
  • Refer to the discard date or beyond-use date on your bottle to learn when your “medication” should be discarded. Compounded medications have a shorter shelf life than those of manufactured drugs. The beyond-use date is the longest date we can guarantee full potency of your medication.
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