Caffeine Citrated

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Nausea, vomiting, stomach upset, headache, trouble sleeping, restlessness, poor feeding, increased urination, rash or dry skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision changes.

In rare (sometimes, fatal) cases, this medication has been associated with a serious stomach condition (necrotizing enterocolitis). Tell your doctor right away if your infant experiences the following: lack of energy (lethargy), severe vomiting, stomach/abdominal bloating (distension), bloody stool.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking caffeine citrate, tell your doctor or pharmacist if your infant is allergic to it; or if your infant has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your infant's medical history, especially of: heart disease, kidney disease, liver disease, stomach problems (such as peptic ulcers, necrotizing enterocolitis), seizures.

Infants may be more sensitive to the side effects of this drug, especially the stimulant effects (such as trouble sleeping, restlessness, nervousness).

Older adults may be more sensitive to the side effects of this drug, especially trouble sleeping.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are: adenosine, cimetidine, dipyridamole, fluvoxamine, lithium, theophylline, vemurafenib.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include stomach pain, anxiety, agitation, confusion, irregular or fast heartbeat, frequent urination, muscle twitching, ringing in the ears, trouble sleeping, and seizures.

Do not share this medication with others.

Lab and/or medical tests (such as caffeine levels, blood sugars) should be done while your infant is taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Read the Patient Information Leaflet if available from your pharmacist before you start giving this drug and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by mouth or through a feeding tube with or without formula as directed by the doctor, usually once daily. The dosage is based on your infant's weight, medical conditions, and response to treatment. Carefully measure each dose with the provided dosing syringe.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Because this product does not contain preservatives, discard any unused medicine after preparing the dose for your infant.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.

If your infant's condition lasts or gets worse, tell your doctor or pharmacist.