FDA-filed SPL labeling · retrieved through openFDA

Terbutaline

Terbutaline is a bronchodilator (airway-opener) used to prevent and relieve bronchospasm in people with asthma, bronchitis, and emphysema.

Brand names BrethineBricanyl
Rx Forms 2 Routes Oral · Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 7 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 →

At a glance
Linked label effectiveNov 15, 2019
Clinical labels in scope ⓘ7
AvailabilityRx
Earliest approval/marketing year ⓘ1974
FDA-listed product records ⓘ42
Boxed warningYes
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 24, 2026
Other forms & routes:
Injection
⭐ Terbutaline at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Terbutaline is a proven airway-opener used to treat bronchospasm in asthma, bronchitis, and emphysema in patients 12 and older. It works quickly — especially as an injection — but it is not a substitute for anti-inflammatory asthma therapy when your condition requires it. Never use it to stop preterm labor at home, and contact your doctor promptly if it stops working as well as it should.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Terbutaline must NOT be used to stop preterm labor for more than 48–72 hours, and should never be used at home or on an ongoing basis to prevent preterm labor. This use is not approved and has caused serious harm, including death, in pregnant women. Risks to the mother include a dangerously fast heart rate, low potassium, abnormal heart rhythms, fluid in the lungs, and reduced blood flow to the heart. The baby's heart rate can also increase, and the newborn may have low blood sugar. If you are pregnant and have been given terbutaline for any reason, talk to your doctor about the risks right away.

Read the full warning on DailyMed →

📖 Terbutaline: Patient Information Guide

A plain-language walkthrough of Terbutaline — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for▾

Terbutaline is a bronchodilator approved to prevent and reverse bronchospasm (sudden airway tightening) in patients 12 years and older. It is available as both a tablet and a subcutaneous injection under the Terbutaline Sulfate brand.

  • Asthma — prevention and reversal of bronchospasm (both tablet and injection forms)
  • Bronchitis — reversible bronchospasm associated with chronic bronchitis (both forms)
  • Emphysema — reversible bronchospasm associated with emphysema (both forms)
⚙️How it works▾

Terbutaline is a beta-2 adrenergic receptor agonist — meaning it latches on to beta-2 receptors, which are found mainly in the smooth muscle that wraps around your airways. When it activates these receptors, it raises levels of a signaling molecule called cAMP inside the muscle cells. Higher cAMP tells those muscles to relax, which widens the airways and makes breathing easier. It also helps stop airway-irritating substances (like those released from mast cells during an allergic response) from being released.

Because beta-2 receptors also exist in small numbers in the heart, terbutaline can have some cardiovascular effects — particularly at higher doses or with the injection form — so heart rate and blood pressure need to be kept in mind.

💊How it's taken▾

Terbutaline Sulfate Tablets are taken by mouth roughly three times a day during waking hours, spaced about six hours apart. Terbutaline Sulfate Injection is given under the skin (subcutaneous) into the upper arm by a healthcare provider; a second dose may be given if there is no improvement within 15–30 minutes, but the total within 4 hours is capped. There are no food-timing restrictions noted in the labeling for either form.

  • Always follow your prescriber's exact instructions — do not adjust your dose on your own
  • If your medication stops working as well as it used to, call your doctor right away rather than taking extra doses
🤒Side effects — in detail▾

Most side effects of terbutaline are related to its stimulant action and are usually temporary:

  • Tremor (shakiness) — especially at higher doses
  • Nervousness or anxiety
  • Headache
  • Dizziness
  • Drowsiness
  • Palpitations (noticeable heartbeat) or fast heart rate
  • Nausea or vomiting
  • Muscle cramps, dry mouth, or flushing

More serious reactions — including significant changes in heart rate or rhythm, chest discomfort, seizures, or severe shortness of breath — require prompt medical attention. If your usual dose stops relieving symptoms, that is a sign your condition may be worsening and you should call your doctor immediately.

⚠️Warnings & precautions▾
  • Worsening asthma: Needing terbutaline more often than usual is a warning sign. Your asthma may be deteriorating and may need a different or additional treatment such as a corticosteroid — don't just take more terbutaline.
  • Heart effects: Terbutaline can raise heart rate, affect blood pressure, and cause ECG (heart tracing) changes. People with coronary artery disease, irregular heart rhythms, or high blood pressure need extra caution.
  • Seizures: Rare cases of seizures have been reported. They stopped when the drug was discontinued.
  • Bronchodilators alone may not be enough: Many asthma patients also need anti-inflammatory therapy (such as inhaled corticosteroids). Talk to your doctor if you rely on terbutaline frequently.
  • Pregnancy — prolonged tocolysis (preterm labor): Terbutaline must never be used to stop preterm labor for more than 48–72 hours or in a home/outpatient setting. Serious risks, including death, have occurred in pregnant women when used this way.
🔀What it interacts with▾

Terbutaline can interact with several types of medicines — tell your prescriber and pharmacist about everything you take:

  • Other sympathomimetic (stimulant-type) drugs: Combined heart effects can be harmful — avoid using them together
  • MAO inhibitors and tricyclic antidepressants: These can amplify terbutaline's effects on blood vessels; do not use terbutaline within 2 weeks of stopping an MAO inhibitor
  • Beta-blockers (e.g., propranolol, atenolol): These block terbutaline's airway-opening action and can trigger severe bronchospasm in asthma patients — generally should not be combined
  • Non-potassium-sparing diuretics (water pills such as furosemide or hydrochlorothiazide): Can worsen low potassium levels and heart rhythm changes when combined with terbutaline
  • Methylxanthines (e.g., theophylline): Animal studies found a risk of heart arrhythmias and sudden death when combined with beta-agonists — clinical significance in humans is not established, but caution is warranted

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it▾
  • Tell your doctor if you have any heart condition — including coronary artery disease, irregular heartbeat (arrhythmia), or high blood pressure
  • Tell your doctor if you have a history of seizures
  • Tell your doctor about all medicines you take, especially antidepressants (MAO inhibitors or tricyclics), beta-blockers, or diuretics
  • Pregnant women: terbutaline is not approved for stopping preterm labor and carries serious risks during pregnancy — discuss any use with your doctor immediately
  • Terbutaline tablets and injection are not recommended for children younger than 12 years old
  • Tell your doctor if you are allergic to terbutaline or similar stimulant medicines (sympathomimetic amines)
🚑If you take too much▾

Too much terbutaline can cause an exaggerated version of its usual side effects — including a very fast heart rate (up to 200 beats per minute), seizures, chest pain, high or low blood pressure, irregular heart rhythm, severe tremor, nausea, dizziness, and low potassium levels. There is no specific antidote. If an overdose is suspected, seek emergency medical care immediately — treatment focuses on stopping the medication and providing supportive care, including cardiac and respiratory monitoring.

📡Pharmacodynamics — effects in the body▾

Terbutaline relaxes the smooth muscle around the airways, leading to measurable improvements in airflow. After a subcutaneous injection, a noticeable change in how easily air moves out of the lungs can occur within 5 minutes, with a clinically significant improvement within 15 minutes and the peak effect at 30 to 60 minutes. The bronchodilating benefit from a subcutaneous dose can last between 1.5 and 4 hours. At recommended doses, cardiovascular effects such as increased heart rate can also occur, since beta-2 receptors exist in small numbers in the heart as well.

🔬Pharmacokinetics — how your body processes it▾

When taken as a tablet, terbutaline is absorbed over about 1 to 3 hours and has an elimination half-life (the time for the body to clear half the drug) of roughly 3.4 hours in asthma patients. When given as a subcutaneous injection, it is absorbed much faster — peak blood levels occur within about 30 minutes. After injection, about 90% of the drug is eventually excreted in the urine, with the majority leaving the body unchanged. The main metabolite (breakdown product) is a sulfate conjugate. The tablet form shows incomplete absorption in some people, with a portion of the dose eliminated via the stool.

📦How to store it▾

Store at 20° to 25°C (68° to 77°F) . Dispense in tightly-closed, light-resistant container (USP).

📄 Written from Terbutaline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

32

Supplements & herbs that interact with Terbutaline

32 supplements and herbal products have documented interactions with Terbutaline 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 · 1
  • Moderate · 22
  • Minor · 9
ACTIVATED CHARCOAL Major BLACK TEA Moderate CAFFEINE Moderate COCOA Moderate COFFEE Moderate COFFEE CHARCOAL Moderate COLA NUT Moderate EPHEDRA Moderate +24 more
Every supplement checked against Terbutaline — ranked by severity The full interaction hub: 1 major · 22 moderate · 9 minor · every one linked to its full report. Check Terbutaline 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.

2

Nutrient depletion considerations

Terbutaline has been associated with lower levels of 2 nutrients 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.

Evidence & significance mix
  • Higher significance · 1
  • Moderate · 1
MAGNESIUM Insignificant Depletion POTASSIUM Moderate Depletion
See the full Terbutaline 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.

🩺 Pharmacist Counseling Corner

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

What is terbutaline actually used for? ▾
Terbutaline is a bronchodilator — it relaxes and opens up the airways in your lungs. It's approved to prevent and relieve bronchospasm (that tight, wheezy feeling when your airways clamp down) in people 12 and older with asthma, chronic bronchitis, or emphysema. It comes as a tablet you take by mouth or an injection that a healthcare provider gives you under the skin.
How quickly does terbutaline work? ▾
The injection form works quite fast — you can notice an improvement in airflow within about 5 minutes, with a more significant benefit kicking in within 15 minutes. The tablet form takes longer, since it's absorbed through your digestive system. If the injection doesn't help within 15 to 30 minutes, a second dose may be given, but if there's still no response after that, your medical team will consider other treatments.
What side effects should I expect — and which ones should make me call my doctor? ▾
The most common things people notice are shakiness (tremor), nervousness, headache, dizziness, and a faster or pounding heartbeat. These are usually temporary and tend to settle down. What you should call your doctor about right away: chest pain or discomfort, a very rapid or irregular heartbeat, a seizure, or shortness of breath that doesn't improve after a dose. And if you find yourself needing terbutaline more often than usual, that's a red flag — call your doctor, because your asthma may be getting worse.
Are there medicines I should avoid while taking terbutaline? ▾
Yes — a few important ones. Beta-blockers (often used for heart conditions or blood pressure, like propranolol) can block terbutaline's effect on your airways and may actually cause severe bronchospasm, so they generally shouldn't be combined. MAO inhibitors and tricyclic antidepressants can amplify terbutaline's effects on your blood vessels — don't use terbutaline within 2 weeks of stopping those. Some water pills (diuretics) can worsen potassium loss and heart rhythm effects when combined with terbutaline. Always tell your prescriber and pharmacist every medicine you take.
I heard terbutaline is used to stop preterm labor. Is that safe? ▾
This is really important: terbutaline is NOT approved for stopping preterm labor, and it should never be used at home or on a long-term basis to prevent it. Using it that way has caused serious harm, including death, in pregnant women — risks include a dangerously fast heart rate, abnormal heart rhythms, low potassium, and fluid on the lungs. Newborns can also be affected. If you're pregnant and have been prescribed terbutaline for any reason, talk to your doctor about the risks right away.
What should I do if my terbutaline tablets stop working as well as they used to? ▾
Don't just take more — contact your doctor right away. If your regular dose isn't giving you the relief it used to, that's often a sign your asthma is getting worse and may need a different or additional treatment, like an anti-inflammatory medicine. Terbutaline alone isn't always enough to control asthma long-term, and your doctor may need to reassess your whole treatment plan.
Is Terbutaline available over the counter? ▾
Terbutaline is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Terbutaline first available? ▾
Terbutaline has been available in the United States since at least 1974, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Terbutaline? ▾
Terbutaline is supplied by 20 manufacturers listed in the FDA NDC Directory, including Amneal Pharmaceuticals of New York LLC, TWi Pharmaceuticals, Inc., Chartwell RX, LLC..

💬 Answers drafted from Terbutaline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

📊Terbutaline supplement interactions32 checked — ranked by severity 🌿Drug & Supplement CheckerTerbutaline vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Terbutaline NDCs & costs 🅰️Browse Drugs A–ZLook up any medication

💊 How Terbutaline comes

Terbutaline is available in 2 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
How this form is used
What it may be used for
  • Terbutaline Sulfate Tablets are used to prevent and reverse bronchospasm in people 12 and older with asthma
  • Terbutaline Sulfate Tablets are used for reversible bronchospasm associated with bronchitis and emphysema
Important instructions
  • Terbutaline Sulfate Tablets are taken by mouth, generally three times daily during waking hours, spaced about six hours apart
  • Terbutaline Sulfate Tablets: the total daily dose should not exceed the amount your prescriber specifies — do not take more than prescribed in any 24-hour period
  • Terbutaline Sulfate Tablets: if side effects are bothersome, your doctor may adjust your dose — never adjust it on your own
  • If Terbutaline Sulfate Tablets stop providing their usual relief, contact your doctor right away — do not simply take more
Available strengths 2 strengths
2.5 mg 5 mg
25 FDA-listed product records ⓘ

Injection

Under the skin
How this form is used
What it may be used for
  • Terbutaline Sulfate Injection is used to prevent and reverse bronchospasm in people 12 and older with asthma
  • Terbutaline Sulfate Injection is used for reversible bronchospasm associated with bronchitis and emphysema
Important instructions
  • Terbutaline Sulfate Injection is given only as a subcutaneous (under-the-skin) injection — it must not be given intravenously (into a vein)
  • Terbutaline Sulfate Injection is injected into the lateral deltoid (upper outer arm) area by a healthcare provider
  • If a meaningful improvement does not occur within 15 to 30 minutes after a Terbutaline Sulfate Injection dose, a second dose may be given — but if there is still no response, other treatments should be considered
  • Terbutaline Sulfate Injection vials are for single patient use — any unused portion should be discarded
Available strengths 1 strength
1 mg/mL
13 FDA-listed product records ⓘ

📊 Terbutaline across the U.S. market

How Terbutaline 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.

2
Dose forms ⓘ
20
Manufacturers
1
Brand names
42
FDA-listed product records ⓘ
1974
First marketed ⓘ

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 (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Amneal Pharmaceuticals of New York LLC10%
TWi Pharmaceuticals, Inc.10%
Chartwell RX, LLC.10%
Lannett Company, Inc.10%
Henry Schein, Inc.7%
Hikma Pharmaceuticals USA Inc.7%
Other makers48%

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

📈 How widely Terbutaline is used

A general measure of how commonly Terbutaline 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 Terbutaline 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.

4,509
Medicaid prescriptions filled (Q1–Q4 2025)
$102,154 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Terbutaline prescribed? Of the 1,597 medications we measure, Terbutaline ranks #1,059 by Medicaid prescriptions — more than 34% of them.

Where Terbutaline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,059 of 1,597
#1,054 Dronabinol 4,723 Rx #1,055 Trofinetide 4,625 Rx #1,056 Pilocarpine Ophthalmic 4,597 Rx #1,057 Malathion Topical 4,594 Rx #1,058 Betamethasone / Calcip... 4,570 Rx #1,059 Terbutaline 4,509 Rx #1,060 Docosanol 4,506 Rx #1,061 Tolmetin 4,475 Rx #1,062 Letermovir 4,462 Rx #1,063 Fidaxomicin 4,446 Rx #1,064 Galantamine 4,431 Rx

Utilization by Terbutaline 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 1 mL / 1 mg/mL injection is the most-dispensed Terbutaline product — about 98% of these Medicaid prescriptions.

1 ML terbutaline sulfate 1 MG/ML Injection Most dispensed

4,399 Medicaid prescriptions (Q1–Q4 2025) 98% of Terbutaline prescriptions shown $98,352 gross reimbursement (before rebates) ≈ $22 per prescription (gross)

Summed across the 3 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857635

terbutaline sulfate 2.5 MG Oral Tablet

75 Medicaid prescriptions (Q1–Q4 2025) 2% of Terbutaline prescriptions shown $1,814 gross reimbursement (before rebates) ≈ $24 per prescription (gross)

Summed across the 2 of 20 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857677

terbutaline sulfate 5 MG Oral Tablet

35 Medicaid prescriptions (Q1–Q4 2025) <1% of Terbutaline prescriptions shown $1,989 gross reimbursement (before rebates) ≈ $57 per prescription (gross)

Summed across the 2 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857683

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 Terbutaline, 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 50 listed Terbutaline NDCs with Medicaid activity.

🔍 Compare Terbutaline products

A representative set of FDA-listed product records for Terbutaline — 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 42 of 42 products — FDA National Drug Code Directory. See every product, package size and price: browse all 42 Terbutaline NDCs →

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) Terbutaline RxCUI 10368 5 dose forms · 6 strengths
  1. Dose form (SCDF) Extended Release Oral Tablet RxCUI 374041 No current FDA listing
    Clinical drug / strength (SCD) 12 HR terbutaline sulfate 7.5 MG RxCUI 865204
  2. Dose form (SCDF) Injectable Solution RxCUI 374038 In current FDA listings
    Clinical drug / strength (SCD) sulfate 0.5 MG/ML RxCUI 857664
  4. Dose form (SCDF) Oral Solution RxCUI 374039 No current FDA listing
    Clinical drug / strength (SCD) sulfate 0.3 MG/ML RxCUI 857660
  5. Dose form (SCDF) Oral Tablet RxCUI 374040 In current FDA listings
    Clinical drug / strength (SCD) sulfate 2.5 MG RxCUI 857677 sulfate 5 MG RxCUI 857683

Look up RxCUI 10368 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.

🏷️ Sold under these brand names

Brethine Bricanyl

🏭 Manufacturers & labelers

Amneal Pharmaceuticals of New York LLC 4 TWi Pharmaceuticals, Inc. 4 Chartwell RX, LLC. 4 Lannett Company, Inc. 4 Henry Schein, Inc. 3 Hikma Pharmaceuticals USA Inc. 3 ANI Pharmaceuticals, Inc. 2 Upsher-Smith Laboratories, LLC 2 Proficient Rx LP 2 Medical Purchasing Solutions. LLC 2 General Injectables & Vaccines, Inc 2 Bora Pharmaceutical Laboratories Inc. 2 Letco Medical, Llc 1 Medical Purchasing Solutions, LLC 1 Melody Healthcare Pvt. Ltd. 1 Professional Compounding Centers of America dba PCCA 1 Fresenius Kabi USA, LLC 1 RedPharm Drug, Inc. 1 Cambrex Profarmaco Milano Srl 1 UBI Pharma Inc. 1

RxNorm drug class

Terbutaline belongs to the Selective beta-2-adrenoreceptor agonists class.

Drug family (ATC) Selective beta-2-adrenoreceptor agonists, Selective beta-2-adrenoreceptor agonists

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.

🔬 Where this comes from

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 Nov 15, 2019
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Terbutaline.
📈
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 Terbutaline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
7
NDC products indexed
42
Distinct labelers/manufacturers represented
20
Linked representative label ⓘ
ANI Pharmaceuticals, Inc.
Linked label effective
Nov 15, 2019
Composite sections available
18
Linked SPL Set ID
d810a15b-3e10-4f6c-a36e-8ddecbaba9c3
Linked SPL Document ID
ee722f8c-05d6-43bc-825d-9496579032c4
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 7 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. ANI Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.