Levonorgestrel
Levonorgestrel is a progestin (a hormone similar to progesterone) used in two main ways: as an intrauterine system (IUS) for long-term pregnancy prevention, and as a tablet for emergency contraception after unprotected sex.
🧬 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 55 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 →
Levonorgestrel is a progestin (a man-made relative of progesterone) used as an intrauterine system (IUS) that prevents pregnancy for years, mainly by thickening mucus at the cervix (Mirena and Liletta also treat heavy periods), and as the familiar morning-after tablet, on the market since about 1982 and available as a generic. Most people tolerate it well; the IUS mainly changes bleeding (spotting, irregular periods or none), and the tablet can bring nausea, tiredness and an off-schedule next period. With an IUS, see your provider promptly for pelvic pain, fever, unusual discharge or a suspected pregnancy. For the tablet, sooner is better, ideally right away and within 72 hours.
Clinical pearls
- If you vomit within 2 hours of the tablet, call a healthcare professional about whether to repeat the dose.
- Efavirenz (an HIV medicine), rifampin and seizure medicines can make the emergency tablet work less well.
- An IUS can slip out without symptoms, so a noticeable increase in bleeding is a clue worth getting checked.
- The tablet is for emergencies only, not regular birth control, and neither form protects against sexually transmitted infections.
Patient information guide A plain-language walkthrough of Levonorgestrel, written from its FDA label.
What Levonorgestrel is used for
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Levonorgestrel is used for contraception, and in some products for heavy menstrual bleeding.
- Mirena (intrauterine): pregnancy prevention for up to 8 years, and heavy menstrual bleeding for up to 5 years in women who choose intrauterine contraception.
- Liletta (intrauterine): pregnancy prevention for up to 8 years, and heavy menstrual bleeding for up to 5 years in patients who choose intrauterine contraception.
- Kyleena (intrauterine): pregnancy prevention for up to 5 years.
- Skyla (intrauterine): pregnancy prevention for up to 3 years.
- Oral tablets (such as AfterPill, AfterPlan and Empowered Choice): emergency contraception to reduce the chance of pregnancy after unprotected sex.
How Levonorgestrel works
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The intrauterine systems release levonorgestrel, a progestin, directly into the uterus. It thickens cervical mucus so sperm can't pass easily, reduces sperm movement and function, and changes the uterine lining.
The label notes the exact local mechanism has not been conclusively shown. Because the effect is mainly local, ovulation often continues in women using these systems.
Levonorgestrel dosage
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The intrauterine systems and the tablets are used very differently.
- Intrauterine systems: placed in the uterus by a trained provider using sterile technique, with a check at 4 to 6 weeks and routine follow-up. They must be removed or replaced at the end of their labeled duration.
- Tablets: taken by mouth as soon as possible within 72 hours (3 days) after unprotected sex. The sooner, the better it works.
- If you vomit within 2 hours of a tablet, call a healthcare professional to ask whether to repeat the dose.
Dosing details from the FDA-approved label
From the Levonorgestrel 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.
- Kyleena - dosing over time (contraception)
- Contains 19.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 17.5 mcg/day after 24 days
- Decreases progressively to 9.8 mcg/day after 1 year and to 7.4 mcg/day after 5 years
- Average in vivo release rate is approximately 12.6 mcg/day over the first year and 9.0 mcg/day over 5 years
- Maximum: Must be removed by the end of the fifth year; can be replaced at the time of removal with a new Kyleena if continued contraceptive protection is desired.
- Inserted by a trained healthcare provider using strict aseptic technique; re-examine and evaluate 4 to 6 weeks after insertion, then yearly or more often if clinically indicated.
- Skyla - dosing over time (contraception)
- Contains 13.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 14 mcg/day after 24 days
- Decreases progressively to approximately 6 mcg/day after 1 year and to 5 mcg/day after 3 years
- Average in vivo release rate is approximately 8 mcg/day over the first year and 6 mcg/day over 3 years
- Maximum: Must be removed by the end of the third year; can be replaced at the time of removal with a new Skyla if continued contraceptive protection is desired.
- Inserted by a trained healthcare provider using strict aseptic technique; re-examine and evaluate 4 to 6 weeks after insertion, then yearly or more often if clinically indicated.
Read the label’s full dosing text
When should I use levonorgestrel tablet 1.5 mg? The sooner you take emergency contraception, the better it works. You should use levonorgestrel tablet 1.5 mg within 72 hours (3 days) after you have had unprotected sex. Levonorgestrel tablet 1.5 mg is a backup or emergency method of birth control you can use when: • your regular birth control was used incorrectly or failed • you did not use any birth control method
Read the full Dosage and Administration section on DailyMed →
Levonorgestrel side effects
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Side effects differ by product.
Common side effects
- Vulvovaginitis (irritation or inflammation of the vagina and vulva) with the intrauterine systems
- Ovarian cysts with the intrauterine systems
- Abdominal or pelvic pain
- Headache or migraine
- Acne
- Painful periods or uterine cramping
- Breast pain
- Menstrual changes, tiredness, dizziness, nausea and vomiting with the tablets
When to get medical help
- Call your provider if you have lower belly or pelvic pain, fever, chills, unusual or foul-smelling discharge, unexplained bleeding, or genital sores. These can signal a pelvic infection.
- Get help right away if you have severe pain soon after IUS placement, especially with fever. Serious infections (sepsis) have been reported.
- Tell your provider if you think you are pregnant while using an IUS. Pregnancy with an IUS in place can be ectopic (outside the uterus), and it raises the risk of miscarriage, infection and early labor.
- Call if you think the IUS has moved or come out, or if you have severe pain or ongoing bleeding. The IUS can perforate (poke through) the uterine wall or be expelled.
- Report lower belly pain with missed periods. This can signal an ectopic pregnancy.
- If you vomit within 2 hours of a levonorgestrel tablet, call a healthcare professional.
- Blood clots, stroke, high blood pressure and allergic reactions (rash, hives, swelling) have been reported with IUS use. Seek care if you notice these.
Seek care for signs of pelvic infection, severe pain, suspected pregnancy with an IUS in place, or a device that has moved or come out.
Levonorgestrel warnings and precautions
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- Pregnancy with an IUS in place raises the risk of ectopic pregnancy, miscarriage, serious infection and premature labor.
- Infection: pelvic inflammatory disease and, rarely, severe infection (sepsis) have been reported after insertion.
- Perforation and expulsion: the IUS can go through the uterine wall or come out. Risk is higher with breastfeeding or recent delivery.
- Ovarian cysts and bleeding changes can occur.
- Tablets: not for regular birth control, won't work if you're already pregnant, and offer no protection against HIV/AIDS or other STDs.
Levonorgestrel interactions
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A few medicines can matter, mostly with the tablets.
- Efavirenz, rifampin and seizure medicines: may reduce how well the tablets work.
- CYP3A4-affecting drugs or herbal products (Kyleena): can change levonorgestrel blood levels, though the contraceptive effect is unlikely to be affected.
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 Levonorgestrel
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- Don't use if you are pregnant.
- Tell your provider about any allergy to levonorgestrel.
- The IUS is not for use with active pelvic infection, untreated genital tract infection, or recent infected abortion or postpartum infection.
- The IUS is not for use with uterine or cervical cancer, breast cancer or other hormone-sensitive cancer, or unexplained uterine bleeding.
- The IUS is not for use with acute liver disease or liver tumor, or a uterine shape problem that blocks proper placement.
- Tell your provider if you are breastfeeding or recently gave birth, since perforation risk is higher.
- The IUS is not indicated before first period or after menopause.
Levonorgestrel overdose
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For the tablets, in case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
What Levonorgestrel does in the body
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The intrauterine systems have mainly local hormone effects in the uterus. Local levonorgestrel causes changes in the uterine lining, including glandular shrinkage and fewer dividing cells.
How your body processes Levonorgestrel
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For Skyla, the drug is released into the uterus at a rate that slowly falls over time. Blood levels peak about 2 days after insertion and then decline. Levonorgestrel is mostly bound to blood proteins and is broken down mainly by the CYP3A4 enzyme. Its half-life after intravenous dosing is about 20 hours, and it leaves the body through urine and stool.
How to store Levonorgestrel
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Store at 20–25°C (68–77°F) Active ingredient: levonorgestrel 1.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Levonorgestrel
191 supplements and herbal products have documented interactions with Levonorgestrel in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 142
- Minor · 43
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.
Nutrient depletion considerations
Levonorgestrel 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.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Levonorgestrel: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Levonorgestrel — the kind of thing our pharmacy team would talk through with you at the counter.
What is levonorgestrel used for?
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How do I take the emergency contraceptive tablet?
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Can I use the tablet as my regular birth control?
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What side effects should I expect?
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Do any of my other medicines matter?
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What if I get pregnant with an IUS in place?
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Is Levonorgestrel available over the counter?
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When was Levonorgestrel first available?
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Who makes Levonorgestrel?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Levonorgestrel on HelloPharmacist
Levonorgestrel forms and strengths (how it comes)
Levonorgestrel 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
How this form is used
- AfterPill is used as a backup or emergency birth control after unprotected sex or when regular birth control failed.
- AfterPlan, Empowered Choice, Amazon Basic Care Levonorgestrel, Econ Morning After and Emergency Contraceptive reduce the chance of pregnancy after unprotected sex.
- AfterPill should be used within 72 hours (3 days) after unprotected sex.
- AfterPlan and Empowered Choice are taken as soon as possible within 72 hours after unprotected sex.
- AfterPlan and Empowered Choice: if you vomit within 2 hours, call a healthcare professional to ask whether to repeat the dose.
Insert or device
How this form is used
- Mirena prevents pregnancy for up to 8 years and treats heavy menstrual bleeding for up to 5 years in women choosing intrauterine contraception.
- Liletta prevents pregnancy for up to 8 years and treats heavy menstrual bleeding for up to 5 years in patients choosing intrauterine contraception.
- Kyleena prevents pregnancy for up to 5 years.
- Skyla prevents pregnancy for up to 3 years.
- Kyleena, Skyla, Mirena and Liletta are placed by a trained healthcare provider using strict aseptic (sterile) technique.
- Kyleena and Skyla must be removed or replaced after 5 and 3 years, respectively.
- Mirena and Liletta must be removed by the end of the eighth year.
- A follow-up exam is advised about 4 to 6 weeks after insertion for these systems.
Levonorgestrel on the U.S. market: products, makers and brands
How Levonorgestrel 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.
31 companies list 62 Levonorgestrel product records with the FDA, mostly as tablet, insert or device; the earliest marketing or approval year on record is 1979. Brand names on the directory include Fallback Solo, Next Choice One Dose, Opcicon One-Step and 13 more; the rest are generics.
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 (20) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Levonorgestrel is used (Medicaid data)
A general measure of how commonly Levonorgestrel 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 Levonorgestrel 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.
How commonly is Levonorgestrel prescribed? Of the 1,601 medications we measure, Levonorgestrel ranks #345 by Medicaid prescriptions — more than 78% of them.
Utilization by Levonorgestrel 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.
levonorgestrel 0.000833 MG/HR Intrauterine System Most dispensed
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 804156
levonorgestrel 1.5 MG Oral Tablet
Summed across the 9 of 95 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 483325
levonorgestrel 0.000729 MG/HR Intrauterine System
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1811886
levonorgestrel 0.000813 MG/HR Intrauterine System
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1605252
levonorgestrel 0.000583 MG/HR Intrauterine System
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1366334
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 Levonorgestrel, 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 13 of 105 listed Levonorgestrel NDCs with Medicaid activity.
Compare Levonorgestrel products
A representative set of FDA-listed product records for Levonorgestrel — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Insert or device | ||||
| 52 mg | Intrauterine | Allergan, Inc. | NDA | View NDC → |
| 13.5 mg | Intrauterine | Bayer HealthCare Pharmaceuticals Inc. | NDA | View NDC → |
| 19.5 mg | Intrauterine | Bayer HealthCare Pharmaceuticals Inc. | NDA | View NDC → |
| 52 mg | Intrauterine | Bayer HealthCare Pharmaceuticals Inc. | NDA | View NDC → |
| 💊Tablet | ||||
| 1.5 mg | Oral | A-S Medication Solutions | NDA | View NDC → |
| 1.5 mg | Oral | Afaxys Pharma, LLC | ANDA | View NDC → |
| 1.5 mg | Oral | Amazon.com Services LLC | ANDA | View NDC → |
| 1.5 mg | Oral | Aurohealth LLC × 5 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Cadence Health Inc × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Camber Consumer Care Inc | ANDA | View NDC → |
| 1.5 mg | Oral | Cardinal Health 110, LLC. DBA Leader | ANDA | View NDC → |
| 1.5 mg | Oral | Foundation Consumer Healthcare LLC × 3 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 1.5 mg | Oral | Foundation Consumer Healthcare LLC × 2 listings | NDA | View NDC → |
| 1.5 mg | Oral | Glenmark Therapeutics Inc., Usa × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Home Health Brands, LLC | ANDA | View NDC → |
| 1.5 mg | Oral | Ingenus Pharmaceuticals, LLC | ANDA | View NDC → |
| 1.5 mg | Oral | Julie Products Inc | ANDA | View NDC → |
| 1.5 mg | Oral | Julie Products Inc. × 5 listings | ANDA | View NDC → |
| 1.5 mg | Oral | L. Perrigo Company × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Leader/ Cardinal Health 110, Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Lupin Pharmaceuticals,Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Naari Pte Limited | ANDA | View NDC → |
| 1.5 mg | Oral | Northstar Rx LLC | ANDA | View NDC → |
| 1.5 mg | Oral | Novel Laboratories, Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | NuCare Pharmaceuticals,Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Ohm Laboratories Inc × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Ohm Laboratories Inc. × 2 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 1.5 mg/1.5 mg | Oral | Rapha Pharmaceuticals, Inc. × 6 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Rugby Laboratories | ANDA | View NDC → |
| 1.5 mg | Oral | Sun Pharmaceutical Industries, Inc. × 3 listings | ANDA | View NDC → |
| 1.5 mg | Oral | Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880 | ANDA | View NDC → |
| 1.5 mg | Oral | Thirty Madison Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Winx Health Inc. | ANDA | View NDC → |
| 1.5 mg | Oral | Xiromed LLC | ANDA | View NDC → |
| 1.5 mg | Oral | Yyba Corp × 2 listings | ANDA | View NDC → |
Showing 62 of 62 products — FDA National Drug Code Directory. See every product, package size and price: browse all 62 Levonorgestrel NDCs →
Levonorgestrel side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Levonorgestrel — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Levonorgestrel in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Levonorgestrel FDA approval history
How Levonorgestrel went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Levonorgestrel 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 Levonorgestrel recalls since July 2021.
✅No Levonorgestrel recalls on record since July 2021Source: 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.
RxCUI 6373 3 dose forms · 9 strengths
-
Dose form (SCDF) Drug Implant RxCUI 378923In current FDA listingsClinical drug / strength (SCD) 75 MGRxCUI 608565 -
Dose form (SCDF) Intrauterine System RxCUI 1856515In current FDA listingsClinical drug / strength (SCD) 0.000583 MG/HRRxCUI 13663340.000729 MG/HRRxCUI 18118860.000813 MG/HRRxCUI 16052520.000833 MG/HRRxCUI 804156 -
Dose form (SCDF) Oral Tablet RxCUI 372591In current FDA listingsClinical drug / strength (SCD) 0.03 MGRxCUI 1055100.0375 MGRxCUI 1055120.75 MGRxCUI 2592181.5 MGRxCUI 483325
Look up RxCUI 6373 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.
Levonorgestrel supply and shortage status
Whether Levonorgestrel is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Levonorgestrel costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 1.5 mg | $6.33 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Levonorgestrel brand names
Levonorgestrel is sold under 16 brand names in the FDA directory — Fallback Solo, Next Choice One Dose, Opcicon One-Step, Plan B One-Step and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Levonorgestrel: manufacturers and labelers
31 companies list Levonorgestrel products with the FDA. By number of product records, the largest are Julie Products Inc., Rapha Pharmaceuticals, Inc., Aurohealth LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 7 more on the FDA NDC directory.
Levonorgestrel drug class (RxNorm)
Levonorgestrel belongs to the Progestin class.
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 Levonorgestrel 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.
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. Foundation Consumer Healthcare LLC 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 →