Skip to the answer

Caffeine

Caffeine is a stimulant used as caffeine citrate (injection or oral solution) to treat apnea of prematurity in premature infants, and in over-the-counter products taken by mouth to help with tiredness and drowsiness.

Brand names Jet-AlertVivarinPep-BackNo DozCafcit +11 more
Drug classes Central Nervous System Stimulant
Rx/OTC Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 15, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 58 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Caffeine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Caffeine is a stimulant that blocks adenosine, a natural brake on the brain. As caffeine citrate, it is the standard hospital treatment for apnea of prematurity (breathing pauses in premature babies), while over-the-counter tablets ease tiredness in adults and children 12 and older; on the U.S. market since about 1984, it is available as a generic. It is usually well tolerated, and jitteriness, a faster heartbeat and more urine are the common effects, plus feeding trouble in infants. In premature babies the care team watches closely for necrotizing enterocolitis, a serious intestinal injury; with tablets, the danger is taking too much, so stay within the package limit.

Clinical pearls

  • Babies treated with theophylline, or whose mothers had caffeine before delivery, need a caffeine blood level checked before starting.
  • Cimetidine and ketoconazole can raise caffeine levels, while phenobarbital and phenytoin can lower them, so doses may need adjusting.
  • Count coffee, tea, soda and energy drinks alongside caffeine tablets, because the stimulant effects stack and too much can cause toxicity.
  • Caffeine tablets are not a substitute for sleep; if tiredness keeps coming back, stop and see a doctor.
How you get itPrescription and over the counter
Comes asTablet, Injection, Topical cream, ointment or gel +1
Earliest FDA record1948
Companies listing it with the FDA44
FDA label last updatedDec 17, 2018
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Caffeine, written from its FDA label.

What Caffeine is used for

▾

Caffeine is used in different ways depending on the product.

  • Caffeine citrate injection and oral solution: short-term treatment of apnea of prematurity in premature infants.
  • Over-the-counter caffeine tablets such as Diurex and the Stay Awake products: taken by mouth by adults (and children 12 and older for Stay Awake) for tiredness and drowsiness.
  • Earthmed Uplift Chewable products are taken by mouth by adults 18 and older.

How Caffeine works

▾

Caffeine is a stimulant that relaxes airway muscles, stimulates the heart muscle, and increases urine flow. How it helps apnea of prematurity is not fully known. It is thought to stimulate the brain’s breathing center and improve breathing.

Most of its effects are attributed to blocking adenosine receptors, which normally slow activity in the body.

Caffeine dosage

▾

Caffeine citrate for premature infants is given by a healthcare team, with a one-time loading dose into a vein and then a maintenance dose about every 24 hours into a vein or by mouth. Doses are based on the infant’s weight.

  • Diurex: for healthy adults, every 3 to 4 hours while symptoms persist, with a daily limit and plenty of water.
  • Stay Awake tablets: adults and children 12 and older, not more often than every 3 to 4 hours.
  • Earthmed Uplift Chewable: adults 18 and older, every 4 to 6 hours with a daily limit. Chew it; do not swallow whole.

Dosing details from the FDA-approved label

From the Caffeine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Loading Dose (caffeine citrate)
    • 1 mL/kg, 20 mg/kg, Intravenous (over 30 minutes) using a syringe infusion pump, one time
    • Dose of caffeine base is one-half the dose expressed as caffeine citrate (e.g., 20 mg of caffeine citrate is equivalent to 10 mg of caffeine base)
  • Maintenance Dose (caffeine citrate)
    • 0.25 mL/kg, 5 mg/kg, Intravenous (over 10 minutes) or Orally, every 24 hours beginning 24 hours after the loading dose
    • Baseline serum caffeine levels should be measured in infants previously treated with theophylline or born to mothers who consumed caffeine prior to delivery; serious toxicity has been associated with serum levels greater than 50 mg/L
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Prior to initiation of caffeine citrate, baseline serum levels of caffeine should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to caffeine. Likewise, baseline serum levels of caffeine should be measured in infants born to mothers who con­sumed caffeine prior to delivery, since caffeine readily crosses the placenta. The recommended loading dose and maintenance doses of caffeine citrate follow. Dose of Caffeine Citrate Dose of Caffeine Citrate Route Frequency Volume mg/kg Loading Dose 1 mL/kg 20 mg/kg Intravenous using a syringe infusion pump One Time (over 30 minutes) Maintenance 0.25 mL/kg 5 mg/kg Intravenous Every Dose (over 10 24 hours beginning 24 hours after the loading dose minutes) or Orally NOTE THAT THE DOSE OF CAFFEINE BASE IS ONE-HALF THE DOSE WHEN EXPRESSED AS CAFFEINE CITRATE (e.g., 20 mg of caffeine citrate is equiva­lent to 10 mg of caffeine base). Serum concentrations of caffeine may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L. Caffeine citrate injection and caffeine citrate oral solution should be inspected visually for particulate matter and discoloration prior to administration. Vials containing discolored solution or visible particulate matter should be discarded. Drug Compatibility To test for drug compatibility with common intravenous solutions or medica­tions, 20 mL of caffeine citrate injection were combined with 20 mL of a solution or medication, with the exception of an Intralipid ® admixture, which was combined as 80 mL/80 mL. The physical appearance of the com­bined solutions was evaluated for precipitation. The admixtures were mixed for 10 minutes and then assayed for caffeine. The admixtures were then continu­ally mixed for 24 hours, with further sampling for caffeine assays at 2, 4, 8, and 24 hours. Based on this testing, caffeine citrate injection, 60 mg/3 mL is chemically stable for 24 hours at room temperature when combined with the following test products.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Caffeine side effects

▾

Reported effects, mostly from premature infants given caffeine citrate, include:

Common side effects

  • Feeding intolerance in infants
  • Rash
  • Irritability, restlessness and jitteriness
  • Fast heart rate (tachycardia)
  • Increased gastric aspirate (stomach contents) and stomach upset
  • Raised or lowered blood sugar
  • Increased urine flow

When to get medical help

  • Necrotizing enterocolitis (serious intestinal injury in premature infants): the care team watches for it closely
  • Seizures, fever, fast breathing, tremor or vomiting, which can signal too much caffeine
  • Signs of serious toxicity such as a fast heartbeat, trouble breathing or heart failure after overdose
  • For over-the-counter tablets: stop use and ask a doctor if tiredness or drowsiness continues or keeps coming back

Caffeine warnings and precautions

▾

The biggest concern with caffeine citrate is necrotizing enterocolitis, a serious intestinal condition in premature infants. A cause-and-effect link has not been proven, but infants are monitored carefully.

Overdose can cause serious toxicity. For over-the-counter tablets, stop use and ask a doctor if tiredness or drowsiness continues or keeps returning.

Caffeine interactions

▾

Caffeine is broken down by the liver enzyme CYP1A2, so other drugs can change its levels.

  • Theophylline: converts to and from caffeine in premature infants; using both is not recommended.
  • Cimetidine and ketoconazole: slow caffeine clearance, so lower doses may be needed.
  • Phenobarbital and phenytoin: speed clearance, so higher doses may be needed.
  • Ketoprofen: reduced urine volume in a small study of healthy adults.

Interactions listed in the FDA-approved label

From the Caffeine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Cimetidine and ketoconazole (drugs that decrease caffeine elimination): Based on adult data, these drugs are reported to decrease caffeine elimination. Lower doses of caffeine may be needed following coadministration.
  • Phenobarbital and phenytoin (drugs that increase caffeine elimination): Based on adult data, these drugs are reported to increase caffeine elimination. Higher caffeine doses may be needed following coadministration.
  • Ketoprofen: Caffeine administered concurrently with ketoprofen reduced the urine volume in four healthy volunteers; the clinical significance in preterm neonates is not known.
  • Theophylline: Interconversion between caffeine and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.
  • CYP1A2 substrates, inhibitors or inducers: CYP1A2 is the major enzyme involved in the metabolism of caffeine, so caffeine has the potential to interact with drugs that are substrates for, inhibit, or induce CYP1A2. Few data exist on drug interactions with caffeine in preterm neonates.
Read the label’s full interactions text

Drug Interactions Cytochrome P450 1A2 (CYP1A2) is known to be the major enzyme involved in the metabolism of caffeine. Therefore, caffeine has the potential to interact with drugs that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2. Few data exist on drug interactions with caffeine in preterm neonates. Based on adult data, lower doses of caffeine may be needed following coadministra­tion of drugs which are reported to decrease caffeine elimination (e.g., cimeti­dine and ketoconazole) and higher caffeine doses may be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbi­tal and phenytoin). Caffeine administered concurrently with ketoprofen reduced the urine volume in four healthy volunteers. The clinical significance of this interaction in preterm neonates is not known. Interconversion between caffeine and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Caffeine

▾
  • Do not use caffeine citrate if allergic to any ingredient.
  • Check caffeine levels first in infants previously given theophylline or born to mothers who had caffeine before delivery.
  • Use caution in premature infants with kidney or liver problems.
  • Over-the-counter tablets should not be used by children under 12.
  • Diurex is for normally healthy adults only.

Caffeine overdose

▾

In premature infants, overdose can cause fever, fast breathing, jitteriness, insomnia, tremor, vomiting, high blood sugar and seizures. Serious toxicity has been linked to blood levels above 50 mg/L. Treatment is mainly supportive and symptom-based, and seizures can be treated with medicines such as diazepam or a barbiturate.

What Caffeine does in the body

▾

Caffeine relaxes bronchial smooth muscle, stimulates the central nervous system and heart muscle, and acts as a diuretic. Its effects are largely attributed to blocking adenosine receptors. In apnea of prematurity, it may stimulate the breathing center and increase ventilation.

How your body processes Caffeine

▾

After a dose by mouth in premature infants, caffeine peaks in the blood in about 30 minutes to 2 hours. Formula feeding did not change this timing. It spreads quickly into the brain. Premature infants clear it slowly, with a half-life of about 3 to 4 days, and most is excreted unchanged in urine. By about 9 months, the body handles it much like an adult’s, with a half-life near 5 hours.

How to store Caffeine

▾

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

208

Supplements & herbs that interact with Caffeine

208 supplements and herbal products have documented interactions with Caffeine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 7
  • Moderate · 155
  • Minor · 46
Every supplement checked against Caffeine — ranked by severity The full interaction hub: 7 major · 155 moderate · 46 minor · every one linked to its full report. Check Caffeine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Caffeine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Caffeine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Caffeine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Caffeine — the kind of thing our pharmacy team would talk through with you at the counter.

What is caffeine citrate used for?

▾
It is used short term to treat apnea of prematurity, which means pauses in breathing in premature infants. It is given as an injection or an oral solution by the healthcare team.

How is it given to a baby?

▾
The baby usually gets a one-time loading dose into a vein, then a smaller maintenance dose about every 24 hours. The maintenance dose can be given into a vein or by mouth. The dose is set by weight, so always follow the prescriber’s instructions.

What side effects should I expect?

▾
Babies may be jittery or irritable, have a fast heart rate, have feeding problems, or have a rash. Blood sugar and urine output can also change. Tell the care team if you notice anything unusual.

Is there anything serious to watch for?

▾
Yes. Necrotizing enterocolitis, a serious intestinal problem in premature infants, was seen in trials. A cause was not proven, and the team watches closely for it. Too much caffeine can cause seizures, fever and fast breathing.

Does it interact with other medicines?

▾
It can. Theophylline should not be used with it, since the two convert into each other in premature infants. Medicines like cimetidine, ketoconazole, phenobarbital and phenytoin can change how much caffeine is needed.

Can I take caffeine tablets for tiredness?

▾
Over-the-counter tablets are for adults and children 12 and older, taken no more often than every 3 to 4 hours. Do not use them in children under 12 as a substitute for sleep. Stop and ask a doctor if tiredness or drowsiness keeps coming back.

Is Caffeine available over the counter?

▾
Both. Some Caffeine products are sold over the counter and others need a prescription. According to their FDA listings, the tablet and topical cream, ointment or gel forms are sold over the counter and the injection and oral solution forms need a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Caffeine first available?

▾
The earliest FDA record we hold for Caffeine is from 1948: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Caffeine was first used.

Who makes Caffeine?

▾
44 companies currently list Caffeine products in the FDA's NDC Directory, including Carolina Cannabis Creations LLC, Earthmed LLC, Armas Pharmaceuticals Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Caffeine on HelloPharmacist

Detailed data & references for Caffeine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Caffeine forms and strengths (how it comes)

Caffeine is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Alert Alert Aid Awake Diurex JET ALERT Regular Strength Stay Awake Vivarin
How this form is used
Important instructions
  • Diurex is for normally healthy adults, taken every 3 to 4 hours while symptoms persist, with a daily limit.
  • Diurex: drink 6 to 8 glasses of water daily.
Available strengths 2 strengths
99 FDA-listed product records ⓘ

Injection

Into a muscle · Into a vein
Brands Cafcit
How this form is used
What it may be used for
  • Caffeine Citrate injection is used for short-term treatment of apnea of prematurity in premature infants.
Important instructions
  • Caffeine Citrate injection starts with a one-time loading dose into a vein over about 30 minutes.
  • Caffeine Citrate maintenance doses are given about every 24 hours, starting 24 hours after the loading dose, into a vein or by mouth.
  • Caffeine Citrate: baseline caffeine blood levels should be checked in infants previously treated with theophylline or born to mothers who had caffeine before delivery.
Available strengths 2 strengths
18 FDA-listed product records ⓘ

Topical cream, ointment or gel

By mouth · Extracorporeal
Brands Earthmed Uplift Chewable Cherry FEELSHION 6% Caffeine 1% Retinol Eye Cream Uplift Chewable
Available strengths 2 strengths
13 FDA-listed product records ⓘ

Oral solution

By mouth
How this form is used
What it may be used for
  • Caffeine Citrate Oral Solution is used for short-term treatment of apnea of prematurity in premature infants.
Important instructions
  • Caffeine Citrate Oral Solution maintenance doses can be given by mouth about every 24 hours, starting 24 hours after the loading dose.
  • Caffeine Citrate Oral Solution: the prescriber sets the dose by the infant’s weight.
Available strengths 2 strengths
11 FDA-listed product records ⓘ

Caffeine on the U.S. market: products, makers and brands

How Caffeine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

44 companies list 64 Caffeine product records with the FDA, mostly as tablet, injection, topical cream, ointment or gel; the earliest marketing or approval year on record is 1948. Brand names on the directory include Jet-Alert, Vivarin, Pep-Back and 13 more; the rest are generics.

4
Dose forms ⓘ
44
Labelers (makers, repackagers, distributors)
23
Brand names
64
FDA-listed product records ⓘ
1948
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Carolina Cannabis Creations LLC6%
Earthmed LLC6%
Armas Pharmaceuticals Inc.3%
Better Living Brands, LLC3%
Chain Drug Marketing Association Inc3%
CVS Pharmacy, Inc.3%
Other makers75%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Caffeine is used (Medicaid data)

A general measure of how commonly Caffeine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Caffeine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

262
Medicaid prescriptions filled (Q1–Q4 2025)
$91,283 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Caffeine prescribed? Of the 1,601 medications we measure, Caffeine ranks #1,437 by Medicaid prescriptions — more than 10% of them.

Where Caffeine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Caffeine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 20 mg/mL oral solution is the most-dispensed Caffeine product — about 74% of these Medicaid prescriptions.

caffeine citrate 20 MG/ML Oral Solution Most dispensed

194 Medicaid prescriptions (Q1–Q4 2025) 74% of Caffeine prescriptions shown $80,426 gross reimbursement (before rebates) ≈ $415 per prescription (gross)

Summed across the 3 of 15 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 849928

3 ML caffeine citrate 20 MG/ML Injection

56 Medicaid prescriptions (Q1–Q4 2025) 21% of Caffeine prescriptions shown $10,855 gross reimbursement (before rebates) ≈ $194 per prescription (gross)

Summed across the 3 of 16 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 849931

caffeine 200 MG Oral Tablet

12 Medicaid prescriptions (Q1–Q4 2025) 5% of Caffeine prescriptions shown $2 gross reimbursement (before rebates) ≈ $0.15 per prescription (gross)

Summed across the 1 of 110 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 198520

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Caffeine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 7 of 141 listed Caffeine NDCs with Medicaid activity.

Compare Caffeine products

A representative set of FDA-listed product records for Caffeine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 64 of 64 products — FDA National Drug Code Directory. See every product, package size and price: browse all 64 Caffeine NDCs →

Caffeine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Caffeine recalls since July 2021.

✅No Caffeine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Caffeine RxCUI 1886 4 dose forms · 5 strengths
  1. Dose form (SCDF) Chewing Gum RxCUI 605093 No current FDA listing
    Clinical drug / strength (SCD) 200 MG RxCUI 605094
  2. Dose form (SCDF) Oral Solution RxCUI 371183 In current FDA listings
    Clinical drug / strength (SCD) citrate 20 MG/ML RxCUI 849928
  3. Dose form (SCDF) Oral Tablet RxCUI 371181 In current FDA listings
    Clinical drug / strength (SCD) 100 MG RxCUI 308853 200 MG RxCUI 198520

Look up RxCUI 1886 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Caffeine brand names

Caffeine is sold under 16 brand names in the FDA directory — Jet-Alert, Vivarin, Pep-Back, No Doz and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Jet-Alert Vivarin Pep-Back No Doz Cafcit stay awake Uplift Chewable Awake Alert Diurex Awake Maximum Strength Alert Aid JET ALERT Regular Strength Stay Awake Maximum Strength FEELSHION 6% Caffeine 1% Retinol Eye Cream Earthmed Uplift Chewable Cherry

Who makes Caffeine: manufacturers and labelers

44 companies list Caffeine products with the FDA. By number of product records, the largest are Carolina Cannabis Creations LLC, Earthmed LLC, Armas Pharmaceuticals Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Carolina Cannabis Creations LLC 4 Earthmed LLC 4 Armas Pharmaceuticals Inc. 2 Better Living Brands, LLC 2 Chain Drug Marketing Association Inc 2 CVS Pharmacy, Inc. 2 Exela Pharma Sciences, LLC 2 Fresenius Kabi USA, LLC 2 Kroger Company 2 Kobayashi Healthcare International, Inc. 2 Micro Labs Limited 2 Sagent Pharmaceuticals 2 Sun Pharmaceutical Industries, Inc. 2 TopCo Associates, LLC 2 United Natural Foods, Inc. dba UNFI 2 Walgreen Company 2 AAA Pharmaceutical, Inc. 1 Army And Air Force Exchange Service 1 Allegiant Health 1 Amerisource Bergen 1 Aurohealth LLC 1 Beijing JUNGE Technology Co., Ltd. 1 Bell Pharmaceuticals, Inc 1 Discount Drug Mart 1

…and 20 more on the FDA NDC directory.

Caffeine drug class (RxNorm)

Caffeine belongs to the Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant, Methylxanthine
Drug family (ATC) Tests for gastric secretion, Other dermatologicals, Xanthine derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Caffeine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 17, 2018
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Caffeine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Caffeine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
58
Finished products in the current FDA directory
64
Companies listing them (makers, repackagers, distributors)
44
FDA labeler codes behind them ⓘ
45
Linked representative label ⓘ
Time Cap Labs, Inc
Linked label effective
Dec 17, 2018
Composite sections available
19
Linked SPL Set ID
d221f66d-06bb-44e8-a01b-f5919f5c52d2
Linked SPL Document ID
7d3e5e3c-3199-5637-e053-2991aa0a0d27
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Time Cap Labs, Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →