Quick answers
- What is Candesartan cilexetil used for?
- The FDA-approved label (Candesartan cilexetil, Golden State Medical Supply, Inc., January 15, 2026) says: “Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Treatment of heart failure (NYHA class II-IV) …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Candesartan cilexetil?
- The “Adverse Reactions” section of the FDA label (Candesartan cilexetil, Golden State Medical Supply, Inc., January 15, 2026) begins: “Most common adverse reactions which caused adult patients to discontinue therapy for: Hypertension were headache (0.6%) and dizziness (0.3%) (6.1). Heart Failure were hypotension (4.1%) (5.3), abnormal renal function (6.3%) (5.4), and hyperkalemia (2.4%) (5.5).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Candesartan cilexetil?
- The “Drug Interactions” section of the FDA label (Candesartan cilexetil, Golden State Medical Supply, Inc., January 15, 2026) begins: “Lithium: Increases in serum lithium concentrations and toxicity (7). NSAIDS use may lead to increased risk of renal impairment and loss of antihypertensive effect (7).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Candesartan cilexetil have a boxed warning?
- Yes. The FDA label for Candesartan cilexetil has a boxed warning (“WARNING: FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Candesartan cilexetil?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Candesartan cilexetil been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started September 13, 2021 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Candesartan cilexetil?
- 10 companies list prescription products of Candesartan cilexetil in the FDA NDC Directory, including ANI Pharmaceuticals, Inc., Viona Pharmaceuticals Inc and Alembic Pharmaceuticals Limited.
What Candesartan cilexetil is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Candesartan cilexetil is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension in adults and children 1 to < 17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. Treatment of heart failure (NYHA class II-IV) …
— FDA label: Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, oral), Candesartan cilexetil, Golden State Medical Supply, Inc.; it covers 4 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: FETAL TOXICITY
. Read it on the full label →
13 of 14 FDA labels for this medicine have a boxed warning.
Candesartan cilexetil boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue candesartan cilexetil as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
Read more of this section
When pregnancy is detected, discontinue candesartan cilexetil as soon as possible. (5.1, 8.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1, 8.1)
— FDA label: Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026. Read the full label on DailyMed →
Candesartan cilexetil side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
Most common adverse reactions which caused adult patients to discontinue therapy for: Hypertension were headache (0.6%) and dizziness (0.3%) (6.1). Heart Failure were hypotension (4.1%) (5.3), abnormal renal function (6.3%) (5.4), and hyperkalemia (2.4%) (5.5).
Read more of this section
To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adult Hypertension Candesartan cilexetil has been evaluated for safety in more than 3600 patients/subjects, including more than 3200 patients treated for hypertension. About 600 of these patients were studied for at least 6 months and about 200 for at least 1 year. In general, treatment with candesartan cilexetil was well tolerated. The overall incidence of adverse events reported with candesartan cilexetil was similar to placebo. The rate of withdrawals due to adverse events in all trials in patients (7510 total) was 3.3% (i.e., 108 of 3260) of patients treated with candesartan cilexetil as monotherapy and 3.5% (i.e., 39 of 1106) of patients treated with placebo. In placebo-controlled trials, discontinuation of therapy due to clinical adverse events occurred in 2.4% (i.e., 57 of 2350) of patients treated with candesartan cilexetil and 3.4% (i.e., 35 of 1027) of patients treated with placebo. The most common reasons for discontinuation of therapy with candesartan cilexetil were headache (0.6%) and dizziness (0.3%). The adverse events that occurred in placebo-controlled clinical trials in at least 1% of patients treated with candesartan cilexetil tablets and at a higher incidence in candesartan cilexetil (n = 2350) than placebo (n = 1027) patients included back pain (3% vs. 2%), dizziness (4% vs. 3%), upper respiratory tract infection (6% vs. 4%), pharyngitis (2% vs. 1%), and rhinitis (2% vs. 1%). Pediatric Hypertension Among children in clinical studies, 1 in 93 children age 1 to < 6 and 3 in 240 age 6 to < 17 experienced worsening renal disease. The association between candesartan and exacerbation of the underlying condition could not be excluded. Heart Failure The adverse event profile of candesartan cilexetil in adult heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In the CHARM program, comparing candesartan cilexetil in total daily doses up to 32 mg once daily (n=3803) with placebo (n=3796), 21.0% of patients discontinued candesartan cilexetil for adverse events vs. 16.1% of placebo patients. 6.2 Postmarketing Experience The following adverse reactions were identified during post-approval use of candesartan cilexetil.
— FDA label: Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026. This is part of the section. Read the full label on DailyMed →
Candesartan cilexetil drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Lithium: Increases in serum lithium concentrations and toxicity (7). NSAIDS use may lead to increased risk of renal impairment and loss of antihypertensive effect (7).
Read more of this section
Combined inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia (7). 7.1 Agents Increasing Serum Potassium Co-administration of candesartan cilexetil with potassium sparing diuretics, potassium supplements, potassium-containing salt substitutes or other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including candesartan cilexetil. Monitor serum lithium levels. 7.3 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including candesartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving candesartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including candesartan may be attenuated by NSAIDs including selective COX-2 inhibitors. 7.4 Combination Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Triple combination of candesartan cilexetil with an ACE-inhibitor and a mineralocorticoid receptor antagonist is generally not recommended. Closely monitor blood pressure, renal function and electrolytes in patients on candesartan cilexetil and other agents that affect the RAS. Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes. Avoid use of aliskiren with candesartan cilexetil in patients with renal impairment (GFR <60 mL/min) [see Contraindications (4)].
— FDA label: Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026. Read the full label on DailyMed →
Candesartan cilexetil dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Starting Dose Target Dose Adult Hypertension (2.1) 16 mg tablet once daily 8 - 32 mg tablet total daily dose Pediatric Hypertension (1 to < 6 years) (2.2) 0.20 mg/kg oral suspension once daily 0.05 - 0.4 mg/kg oral suspension once daily or consider divided dose Pediatric Hypertension (6 to < 17 years) (2.2) < 50 kg 4 – 8 mg tablet once daily > 50 kg 8 – 16 mg tablet once daily < 50 kg 4 – 16 mg tablet once daily or consider divided dose > 50 kg 4 – 32 mg tablet once daily or consider divided dose Adult Heart Failure (2.3) 4 mg tablet once daily 32 mg tablet once daily 1 1 The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by patient. 2.1 Adult Hypertension Dosage must be individualized.
Read more of this section
Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with candesartan cilexetil. Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see Clinical Pharmacology (12.3)]. Candesartan cilexetil may be administered with or without food. If blood pressure is not controlled by candesartan cilexetil alone, a diuretic may be added. Candesartan cilexetil may be administered with other antihypertensive agents. 2.2 Pediatric Hypertension 1 to < 17 Years of Age Candesartan cilexetil may be administered once daily or divided into two equal doses. Adjust the dosage according to blood pressure response. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate candesartan cilexetil under close medical supervision and consider administration of a lower dose [see Warnings and Precautions (5.3)]. Children 1 to < 6 years of age: The dose range is 0.05 to 0.4 mg/kg per day. The recommended starting dose is 0.20 mg/kg (oral suspension). Children 6 to < 17 years of age: For those less than 50 kg, the dose range is 2 to 16 mg per day. The recommended starting dose is 4 to 8 mg. For those greater than 50 kg, the dose range is 4 to 32 mg per day. The recommended starting dose is 8 to 16 mg. Doses above 0.4 mg/kg (1 to < 6 year olds) or 32 mg (6 to < 17 year olds) have not been studied in pediatric patients [see Clinical Studies (14.1)]. An antihypertensive effect is usually present within 2 weeks, with full effect generally obtained within 4 weeks of treatment with candesartan cilexetil. Children < 1 year of age must not receive candesartan cilexetil for hypertension. All pediatric patients with a glomerular filtration rate less than 30 mL/min/1.73m 2 should not receive candesartan cilexetil since candesartan cilexetil has not been studied in this population [see Use in Specific Populations (8.4)].
Table from the label
| Starting Dose | Target Dose | |
|---|---|---|
| Adult Hypertension (2.1) | 16 mg tablet once daily | 8 - 32 mg tablet total daily dose |
| Pediatric Hypertension (1 to < 6 years) (2.2) | 0.20 mg/kg oral suspension once daily | 0.05 - 0.4 mg/kg oral suspension once daily or consider divided dose |
| Pediatric Hypertension (6 to < 17 years) (2.2) | < 50 kg 4 – 8 mg tablet once daily > 50 kg 8 – 16 mg tablet once daily | < 50 kg 4 – 16 mg tablet once daily or consider divided dose > 50 kg 4 – 32 mg tablet once daily or consider divided dose |
| Adult Heart Failure (2.3) | 4 mg tablet once daily | 32 mg tablet once daily 1 |
— FDA label: Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026. This is part of the section. Read the full label on DailyMed →
Candesartan cilexetil in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Candesartan cilexetil can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
Read more of this section
Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue candesartan cilexetil as soon as possible. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Pregnant women with chronic heart failure are at increased risk for preterm birth. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Heart failure may worsen with pregnancy and may lead to maternal death. Closely monitor pregnant patients for destabilization of their heart failure. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe infants with histories of in utero exposure to candesartan cilexetil for hypotension, oliguria, hyperkalemia or other symptoms of renal impairment [see Use in Specific Populations (8.4)]. In neonates with a history of in utero exposure to candesartan cilexetil, if oliguria or hypotension occurs, support blood pressure and renal perfusion.
— FDA label: Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026. This is part of the section. Read the full label on DailyMed →
When Candesartan cilexetil should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Candesartan cilexetil is contraindicated in patients who are hypersensitive to candesartan. Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes [see Drug Interactions (7.4)]. Known hypersensitivity to product components (4). Do not co-administer aliskiren with candesartan cilexetil in patients with diabetes (4).
— FDA label: Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026. Read the full label on DailyMed →
Candesartan cilexetil overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
No lethality was observed in acute toxicity studies in mice, rats, and dogs given single oral doses of up to 2000 mg/kg of candesartan cilexetil.
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In mice given single oral doses of the primary metabolite, candesartan, the minimum lethal dose was greater than 1000 mg/kg but less than 2000 mg/kg. The most likely manifestation of overdosage with candesartan cilexetil would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Candesartan cannot be removed by hemodialysis. Treatment: To obtain up-to-date information about the treatment of overdose, consult your Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and altered pharmacokinetics in your patient.
— FDA label: Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 40 in the FDA NDC Directory |
| Brand names | Atacand |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| candesartan cilexetil 16 mg tablet | Generic | $0.4980 per tablet |
| candesartan cilexetil 16 mg tablet | Brand: Atacand | $7.85 per tablet |
| candesartan cilexetil 32 mg tablet | Generic | $0.5530 per tablet |
| candesartan cilexetil 32 mg tablet | Brand: Atacand | $9.90 per tablet |
| candesartan cilexetil 4 mg tablet | Generic | $0.5617 per tablet |
| candesartan cilexetil 8 mg tablet | Generic | $0.5246 per tablet |
NADAC list of November 4, 2026; these prices took effect between July 22, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- ANI Pharmaceuticals, Inc.8 products
- Viona Pharmaceuticals Inc4 products
- Alembic Pharmaceuticals Limited4 products
- Mylan Pharmaceuticals Inc.4 products
- Zydus Lifesciences Limited4 products
- Macleods Pharmaceuticals Limited4 products
- Golden State Medical Supply, Inc.4 products
- Alembic Pharmaceuticals Inc.4 products
- Bryant Ranch Prepack2 products
- NorthStar RxLLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020838 ATACAND | Ani Pharms | June 4, 1998 | 29, latest June 24, 2020 2020: Labeling · 2016: Labeling · 2015: Labeling |
Generic approvals (5)
- ANDA078702Mylan · May 3, 2013
- ANDA203813Macleods Pharms · December 5, 2016
- ANDA209119Alembic · June 20, 2017
- ANDA091390Zydus Lifesciences · August 23, 2017
- ANDA210302Alembic · December 4, 2018
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 13, 2021 · Class III · Terminated · D-0798-2021
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93 — Viatris
-
March 22, 2021 · Class III · Terminated · D-0329-2021
Failed Impurities/Degradation Specifications
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-1 — Macleods Pharma Usa Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- AtacandBrand page: products, maker and price
- Heart failureCondition named on the label: hospitals that treat it
- High blood pressureCondition named on the label: hospitals that treat it
- StrokeCondition named on the label: hospitals that treat it
- ANI Pharmaceuticals, Inc.Maker or distributor
- Viona Pharmaceuticals IncMaker or distributor
- Alembic Pharmaceuticals LimitedMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Candesartan cilexetil, Golden State Medical Supply, Inc., effective January 15, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →