No Doz Maximum Strength (Oral)

Caffeine tablets are used to help you stay awake when you feel drowsy or unusually tired or weak. Do not use this medicine instead of getting sleep.

Caffeine oral solution is used to treat short-term apnea of prematurity, which occurs when premature babies (infants between 28 and 32 weeks gestational age) stop breathing. Apnea of prematurity happens because the baby's breathing centers are not fully developed.

This medicine can be obtained with or without a prescription from your doctor.

Your doctor will monitor your progress closely while you or your child are taking this medicine. This helps your doctor determine if the medicine is effective and whether you should keep taking it.

If you are using caffeine solution:

• Call your baby's doctor immediately if your baby continues to have apnea.
• Inform your baby's doctor right away if your baby shows any of these signs: faster heartbeat, increased diaper wetting, restlessness, jitteriness, or shaking.
• Contact your baby's doctor right away if your baby experiences any of these symptoms: abdominal or stomach distension, vomiting, or bloody stools. These could be signs of a serious bowel or stomach issue.
• Do not adjust your baby's dose without first consulting your baby's doctor.

If you are using caffeine tablets:

• Limit the intake of medicines, foods, or drinks that contain caffeine. Taking too much caffeine can lead to nervousness, irritability, sleeplessness, and a rapid heartbeat.
• Talk to your doctor if you experience drowsiness, tiredness, or weakness that keeps returning.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important things to consider for this medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know if you have allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to understand how caffeine tablets affect children younger than 12 years of age. Their safety and effectiveness have not been established.

Studies so far have not shown any specific problems in premature babies that would limit the use of caffeine oral solution.

Geriatric

There is no information available on how caffeine affects older patients.

Breast Feeding

Studies in women suggest that this medicine poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. If you are taking this medicine, it is very important for your healthcare professional to know about any other medicines you are using. The following interactions are significant but not all-inclusive.

Using this medicine with the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of your other medicines.

• Riociguat
• Viloxazine

Using this medicine with the following medicines is usually not recommended but may be necessary in some cases. If prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Capmatinib
• Givosiran
• Iobenguane I 131
• Peginterferon Alfa-2b
• Pixantrone
• Ritlecitinib
• Tocilizumab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods as interactions may happen. Using alcohol or tobacco with certain medicines can also lead to interactions. The following interactions are significant but not all-inclusive.

Using this medicine with the following is usually not recommended but may be unavoidable in some cases. If used together, your doctor may adjust the dose or give you special instructions regarding food, alcohol, or tobacco.

• Tobacco

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Anemia or
• Central nervous system problems or
• Heart or blood vessel problems or
• Lung disease or breathing problems (e.g., obstructive apnea) or
• Sepsis (infection in the blood)—Should be treated or ruled out before using caffeine oral solution.

• Kidney disease or
• Liver disease—Use cautiously. The effects may be stronger due to slower removal of caffeine oral solution from the body.

• Necrotizing enterocolitis or
• History of seizures—Use cautiously. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Feeding intolerance

Less common

• Agitation
• black, tarry stools
• blood in the stools or urine
• bruising
• burning feeling or tenderness in the stomach
• chills
• coma
• confusion
• coughing or vomiting blood
• decreased urine output
• depression
• dizziness
• fainting
• fast heartbeat
• fever
• headache
• hostility
• indigestion
• irritability
• lethargy
• lightheadedness
• muscle twitching
• nausea
• persistent bleeding
• rapid, shallow breathing
• rapid weight gain
• rash
• seizures
• severe stomach pain
• stomach upset
• stupor
• swelling of the face, ankles, or hands
• trouble breathing
• unusual tiredness or weakness
• vomiting
• vomiting of blood or material that looks like coffee grounds

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Irritability
• nervousness
• rapid heartbeat
• trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Rash

Less common

• Dry skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Cafcit
• Lucidex
• No Doz Maximum Strength
• Revive
• Stay Awake
• Vivarin

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: CNS Stimulant

Chemical Class: Methylxanthine

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, talk to your doctor.

Swallow the tablets whole. Do not break, crush, or chew it.

If you are using the oral liquid:

• Give this medicine at the same time each day.
• Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
• This medicine may be given through mouth or a feeding tube.
• You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (solution):For treatment of apnea of prematurity: Premature babies—Dose is based on body weight and must be determined by your baby's doctor. The dose is usually given once a day.
• For oral dosage form (tablets):For mental alertness or wakefulness: Adults and children 12 years of age and older—200 milligrams (mg) not more often than every 3 to 4 hours per day. Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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