Provocholine

Provocholine is an FDA-registered drug product whose active ingredient is METHACHOLINE CHLORIDE. It is labelled by Methapharm Inc. taken by respiratory (inhalation) and marketed as a human prescription drug product. Identifiers on file: NDC 64281-100, application NDA019193, label effective 20260715. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing METHACHOLINE CHLORIDE are most often described in connection with: methacholine challenge, test indicated, diagnosis bronchial, airway hyperreactivity, pediatric patients, five years, clinically apparent, usage provocholine. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. Provocholine, a cholinergic agonist used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma (1)

2 DOSAGE AND ADMINISTRATION The methacholine challenge test should be conducted in a pulmonary function laboratory or clinic, by adequately trained personnel, for safety and accuracy (2.1) Determine baseline FEV1 values to assess whether a patient is able to undergo the methacholine challenge test (2.1) See the Full Prescribing Information for the required reconstitution and dilution procedures prior to use (2.2). Recommended dosage(s) of Provocholine in the Methacholine Challenge Test is administration of increasing strengths of Provocholine solution via nebulization (2.3) Administer using either the 5-Breath Dosimeter Dosing Method or the 1-Minute Tidal Breathing Dosing Method with the doubling or quadrupling stepwise protocols (2.4, 2.5) See the full Prescribing Information for administration of inhaled β-agonist after Methacholine Challenge Test (2.6) See the Full Prescribing Information for the interpretation of the results and calculation of hyperresponsiveness (2.7) 2.1 Preparation and Administration Overview Provocholine powder for inhalation solution requires reconstitution and dilution prior to use [see Dosage and Administration (2.2)]. Provocholine inhalation solution in a ready-to-use kit does not require reconstitution and/ or silution prior to use. Provocholine inhalation solution 16 mg/mL in a single-dose vial requires dilution prior to use [see Dosage and Administration (2.2)] . For safety and accuracy, administer Provocholine during a methacholine challenge test in a pulmonary function laboratory or clinic, by an adequately trained personnel. Only healthcare providers trained in and thoroughly familiar with all aspects of the test’s technique and management of respiratory distress should perform the test. Emergency medication and equipment should be immediately available to treat acute respiratory distress. Consider Provocholine use in patients on chronic asthma drugs if the accuracy of the asthma diagnosis is in doubt. In these patients, only administer Provocholine if spirometry is normal after supervised withdrawal of the asthma drugs. Provocholine is not recommended for use in patients with clinically apparent asthma or wheezing. Before starting a methacholine challenge test, baseline spirometry must be performed. For a patient to be able to undergo the test, he or she must present with baseline FEV 1 (Forced Expiratory Volume in 1 second) greater than or equal to 60% of the predicted value (in adults and children) and greater than or equal to 1.5 L (in adults). Provocholine is contraindicated in adult and pediatric patients with baseline FEV1 < 60% predicted or in adults with FEV 1 < 1.5 L [see Contraindications (4) and Warnings and Precautions (5.1)]. At commencement of the methacholine challenge test and prior to administration of Provocholine, a post-diluent FEV 1 must be measured following nebulization of the diluent or base solution (contains no methacholine chloride) [ see Dosage and Administration (2.4, 2.5)]. Administer Provocholine by oral inhalation, with or without food, using either the 5-Breath Dosimeter Dosing Method or the 1-Minute Tidal Breathing Dosing Method with the dose doubling or quadrupling protocols [see Dosage and Administration (2.3, 2.4, 2.5)]. Discard any unused solution from the nebulizer after each administration. The methacholine challenge test is considered positive if there is a reduction of FEV 1 of 20% or more from the post-diluent FEV 1 . The test should be stopped at this point. Calculate and record the FEV 1 reduction value before starting the test [see Dosage and Administration (2.3, 2.4, 2.5)]. After the methacholine challenge test with Provocholine, administer an inhaled β-agonist to expedite the return of the FEV 1 to baseline and to relieve any discomfort the patient may experience. Most patients revert to normal pulmonary function within 10 to 20 minutes following administration of an inhaled β-agonist [see Dosage and Administration (2.6)]. 2.2 Reconstitution and/or Dilution Instructions for Provocholine Powder for Inhalation Solution and Provocholine Inhalation Solution 16 mg/mL (in Single-Dose Vial) Reconstitution and Dilution of Provocholine Powder for Inhalation Solution Reconstitute Provocholine Powder for Inhalation Solution by adding 6.25 mL of 0.9% Sodium Chloride Injection to the supplied vial(s) containing 100 mg of Provocholine powder. Shake the vial to obtain a clear solution. Dilute the reconstituted Provocholine solution, using sterile, empty USP Type 1 borosilicate glass vials. Dilute the reconstituted Provocholine solution with 0.9% Sodium Chloride Injection based on Table 1 to obtain doubling strengths or Table 2 to obtain quadrupling strengths. After adding the 0.9% Sodium Chloride Injection, shake each vial to obtain a clear solution. If not used immediately, refrigerate the reconstituted and diluted solutions at 36°F to 46°F (2°C to 8°C) for up to 2 weeks. Since the temperature of the solution affects nebulizer output, take the diluted solutions out of the refrigerator and allow them to equilibrate to room temperature (approximately 30 minutes) before use. Table 1: Reconstitution and Dilution Instructions for Provocholine Powder for Inhalation Solution to Obtain Doubling Strengths TAKE Add 0.9% Sodium Chloride Injection Provocholine Solution Strength after reconstitution or dilution 100 mg of Provocholine Powder in one single-dose vial 6.25 mL 16 mg/mL 3 mL of 16 mg/mL Provocholine Solution 3 mL 8 mg/mL 3 mL of 8 mg/mL Provocholine Solution 3 mL 4 mg/mL 3 mL of 4 mg/mL Provocholine Solution 3 mL 2 mg/mL 3 mL of 2 mg/mL Provocholine Solution 3 mL 1 mg/mL 3 mL of 1 mg/mL Provocholine Solution 3 mL 0.5 mg/mL 3 mL of 0.5 mg/mL Provocholine Solution 3 mL 0.25 mg/mL 3 mL of 0.25 mg/mL Provocholine Solution 3 mL 0.125 mg/mL 3 mL of 0.125 mg/mL Provocholine Solution 3 mL 0.0625 mg/mL Table 2: Reconstitution and Dilution Instructions for Provocholine Powder for Inhalation Solution to Obtain Quadrupling Strengths TAKE Add 0.9% Sodium Chloride Injection Provocholine Solution Strength after reconstitution or dilution 100 mg of Provocholine Powder in one single-dose vial 6.25 mL 16 mg/mL 3 mL of 16 mg/mL Provocholine Solution 9 mL 4 mg/mL 3 mL of 4 mg/mL Provocholine Solution 9 mL 1 mg/mL 3 mL of 1 mg/mL Provocholine Solution 9 mL 0.25 mg/mL 3 mL of 0.25 mg/mL Provocholine Solution 9 mL 0.0625 mg/mL Dilution of Provocholine Inhalation Solution 16 mg/mL (in a Single-Dose Vial) Transfer the contents of the specified number of 3 mL vials (as per Tables 3 or 4) of Provocholine inhalation solution 16 mg/mL (in Single-Dose Vial) into a sterile, empty USP Type 1 borosilicate glass vial. Swirl the glass vial gently to mix. Dilute the solution with 0.9% Sodium Chloride Injection based on Table 3 (to obtain doubling strengths) or Table 4 (to obtain quadrupling strengths). After adding 0.9% Sodium Chloride Injection, shake each vial to obtain a clear solution. If not used immediately, refrigerate the diluted solutions at 36oF to 46oF (2oC to 8oC) for up to 2 weeks. Since the temperature of the solution affects nebulizer output, take the diluted solutions out of the refrigerator and allow them to equilibrate to room temperature (approximately 30 minutes) before use. Table 3: Dilution Instructions for Provocholine Inhalation Solution 16 mg/mL (in Single-Dose Vial) to Obtain Doubling Strengths TAKE Add 0.9% Sodium Chloride Injection Provocholine Solution Strength after dilution Provocholine Inhalation Solution 16 mg/mL (2 x 3 mL vial) None 16 mg/mL 3 mL of 16 mg/mL Provocholine Solution 3 mL 8 mg/mL 3 mL of 8 mg/mL Provocholine Solution 3 mL 4 mg/mL 3 mL of 4 mg/mL Provocholine Solution 3 mL 2 mg/mL 3 mL of 2 mg/mL Provocholine Solution 3 mL 1 mg/mL 3 mL of 1 mg/mL Provocholine Solution 3 mL 0.5 mg/mL 3 mL of 0.5 mg/mL Provocholine Solution 3 mL 0.25 mg/mL 3 mL of 0.25 mg/mL Provocholine Solution 3 mL 0.125 mg/mL 3 mL of 0.125 mg/mL Provocholine Solution 3 mL 0.0625 mg/mL Table 4: Dilution Instructions for Provocholine Inhalation Solution 16 mg/mL (in Single-Dose Vial) to Obtain Quadrupling Strengths TAKE Add 0.9% Sodium Chloride Injection Provocholine Solution Strength after dilution Provocholine Inhalation Solution 16 mg/Ml (1 x 3 mL vial) None 16 mg/mL 1 mL of 16 mg/mL Provocholine Solution 3 mL 4 mg/mL 1 mL of 4 mg/mL Provocholine Solution 3 mL 1 mg/mL 1 mL of 1 mg/mL Provocholine Solution 3 mL 0.25 mg/mL 1 mL of 0.25 mg/mL Provocholine Solution 3 mL 0.0625 mg/mL 2.3 Recommended Provocholine Doses for Methacholine Challenge Test The recommended doses of Provocholine for oral inhalation for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older during a methacholine challenge test, based on the dose doubling or quadrupling protocol, are provided in Table 5. Table 5: Recommended Provocholine Doses for Methacholine Challenge Test Based on Dose Doubling or Quadrupling Dilution Doubling Protocol Provocholine strength Recommended Volume Provocholine Dose* 0.0625 mg/mL At least 2 mL 1.484 mcg 0.125 mg/mL 2.969 mcg 0.25 mg/mL 5.938 mcg 0.5 mg/mL 11.875 mcg 1 mg/mL 23.75 mcg 2 mg/mL 47.5 mcg 4 mg/mL 95 mcg 8 mg/mL 190 mcg 16 mg/mL 380 mcg Quadrupling Protocol or Ready-to-Use Kit Provocholine strength Recommended Volume Provocholine Dose* 0.0625 mg/mL At least 2 mL 1.484 mcg 0.25 mg/mL 5.938 mcg 1 mg/mL 23.75 mcg 4 mg/mL 95 mcg 16 mg/mL 380 mcg *Provocholine dose was based on the Hudson RCI® MicroMist® Small Volume Nebulizer using dry compressed air to power the nebulizer with a pressure regulator set to 50 lb/in 2 (psi) and flow controller set to flow rate of 4.5 LPM (liters per minute) with a nebulization time of one (1) minute. Under these conditions, the device output was within 10% of 0.13 mL/min (or g/min) (measured gravimetrically), the measured MMD was found to be 3.4 μm, i.e. within the acceptable range of MMD of 1.0 – 3.6 μm. The delivered dose of the respirable fraction for the Provocholine 16 mg/mL inhalation solution was about 380 mcg. 2.4 Determination of Post-Diluent FEV1 and Administration of Provocholine Using the 5-Breath Dosimeter Dosing Method Determination of Post-Diluent FEV 1 Prior to Administration of Provocholine Prior to administration of Provocholine, determine thepost-diluent FEV 1 value required for the methacholine challenge test. Instill diluent (sterile 0.9% Sodium Chloride Injection) or base solution into the nebulizer. If using Provocholine powder for inhalation solution or Provocholine inhalation solution 16 mg/mL (in single-dose vial), using a 3 mL syringe and needle, draw up 2 to 3 mL of diluent (sterile 0.9% Sodium Chloride Injection), and instill the 0.9% Sodium Chloride Injection into the nebulizer using a sterile bacterial-retentive filter (porosity 0.22 μm). If using the Provocholine inhalation solution ready-to-use kit, instill the contents of the base solution (contains no methacholine chloride) into the nebulizer. 2. Instruct the patient to hold the nebulizer upright with the mouthpiece in his/her mouth. The patient should wear a nose clip while inhaling from the nebulizer. 3. At the end of exhalation during tidal breathing (functional residual capacity), instruct the patient to inhale slowly and deeply through the mouthpiece. Trigger the dosimeter soon after oral inhalation begins. Encourage the patient to continue inhaling slowly (about 5 seconds to complete the inhalation) and to hold the breath at total lung capacity (TLC) for another 5 seconds. 4. Repeat Step 3 for a total of five inspiratory capacity inhalations. Take no more than 2 minutes to perform these 5 inhalations. 5. Perform spirometry and measure the FEV 1 30 and 90 seconds after the fifth inhalation from the nebulizer to obtain the post-diluent FEV 1 value. These values may be left at ambient (spirometer) temperature pressure saturated (ATPS). If the FEV 1 value is not of acceptable quality, repeat the procedure. If the post-diluent FEV 1 falls by ≥ 20% from baseline FEV 1 , do not proceed with administration with Provocholine and administer an inhaled β-agonist [see Dosage and Administration (2.6)]. If the post-diluent FEV 1 falls by< 20% from baseline FEV1, proceed to Step 6. Administer of Provocholine Using the 5-Breath Dosimeter Dosing Method 6. Instill Provocholine solution into the nebulizer If using Provocholine powder for inhalation solution or Provocholine inhalation solution 16 mg/mL (in single-dose vial), using a 3 mL syringe and needle, draw up at least 2 mL of the recommended Provocholine strength based on the dose doubling or quadrupling protocol in Table 5 [see Dosage and Administration (2.3)] and instill into the nebulizer using a sterile bacterial-retentive filter (porosity 0.22 μm). Refer to Tables 1, 2, 3 or 4 for preparation of the doubling or quadrupling strengths of Provocholine [see Dosage and Administration (2.2)] . If using the Provocholine inhalation solution ready-to-use kit, instill at least 2 mL of the recommended Provocholine strength based on the dose quadrupling protocol in Table 5 [see Dosage and Administration (2.3)] into the nebulizer. 7. Repeat Steps 2 through 5 for each Provocholine strength, emptying the nebulizer between each strength. To keep the cumulative effect of Provocholine relatively constant, the time interval between the end of one strength and beginning of the subsequent strength should not be more than 5 minutes. 8. Stop dosing if the FEV 1 has fallen ≥ 20% from the post-diluent FEV 1 , or the highest Provocholine strength (16 mg/mL) has been administered (whichever comes first). Do not administer additional Provocholine doses if severe bronchoconstriction occurs [see Warnings and Precautions (5.1) ]. After the test is completed, administer an inhaled β-agonist to the patient [see Dosage and Administration (2.6)]. 9. Wash and clean reusable nebulizers thoroughly according to manufacturer's recommendations. 2.5 Determination of Post-Diluent FEV 1 and Administration of Provocholine Using the 1-Minute Tidal Breathing Dosing Method Determination of Post-Diluent FEV 1 Prior to Administration of Provocholine Prior to administration of Provocholine, determine the post-diluent FEV 1 required for the methacholine challenge test. Instill diluent (sterile 0.9% Sodium Chloride Injection) or base solution into the nebulizer. If using Provocholine powder for inhalation solution or Provocholine inhalation solution 16 mg/mL (in single-dose vial), using a 3 mL syringe and needle, draw up 2 to 3 mL of diluent (sterile 0.9% Sodium Chloride Injection). Instill the 0.9% Sodium Chloride Injection into the nebulizer using a sterile bacterial-retentive filter (porosity 0.22 μm). Attach the nebulizer and necessary tubing to the dry compressed air source. If using the Provocholine inhalation solution ready-to-use kit, instill the contents of the base solution (contains no methacholine chloride) into the nebulizer. 2. Place the face mask loosely over the nose and mouth or the mouthpiece in the mouth (with a nose clip) of the patient. Instruct the patient to hold the nebulizer to avoid warming the solution. Keep the nebulizer upright and vertical. 3. Set the pressure regulator to 50 lb/in 2 (psi) and start the nebulizer by setting the flow controller to a flow rate of 4.5 LPM. Start the stopwatch immediately. 4. Instruct the patient to relax and breath the aerosol quietly (tidal breathing) for 1 minute of inhalation time. 5. After exactly 1 minute of tidal breathing, turn off the nebulizer and flow meter, remove the face mask (or the mouthpiece from the mouth), and discard any remaining solution. 6. Perform spirometry and measure the FEV 1 30 and 90 seconds after the end of 1-minute tidal breathing to obtain the post-diluent FEV 1 . These values may be left at ambient (spirometer) temperature pressure saturated (ATPS). If the FEV 1 value is not of acceptable quality, repeat the procedure. If the post-diluent FEV 1 falls by ≥ 20% from baseline FEV1, do not proceed with administration of Provocholine and administer an inhaled β-agonist to the patient [see Dosage and Administration (2.6)] . If the post-diluent FEV 1 falls by < 20% from baseline FEV 1 , proceed to Step 7. Administration of Provocholine Using the 1-Minute Tidal Breathing Dosing Method 7. Instill Provocholine solution into the nebulizer. If using Provocholine powder for inhalation solution or Provocholine inhalation solution 16 mg/mL (in single-dose vial), using a 3 mL syringe and needle, draw up at least 2 mL of the recommended Provocholine strength based on the dose doubling or quadrupling protocol in Table 5 [see Dosage and Administration (2.3)] and instill into the nebulizer using a sterile bacterial-retentive filter (porosity 0.22 μm). Refer to Tables 1, 2, 3 and 4 for preparation of the doubling and quadrupling strengths of Provocholine [see Dosage and Administration (2.2)]. If using the Provocholine inhalation solution ready-to-use kit, instill at least 2 mL of the recommended Provocholine strength, based on the dose quadrupling protocol in Table 5 [see Dosage and Administration (2.3)] into the nebulizer. 8. Repeat steps 2 through 6 for each Provocholine strength, emptying the nebulizer between each strength or dose. However, stop dosing if the FEV 1 has fallen by ≥ 20% from the post-diluent FEV 1 or the highest Provocholine strength (16 mg/mL) has been administered (whichever comes first). Do not administer additional Provocholine doses if severe bronchoconstriction occurs [see Warnings and Precautions (5.1)]. 9. After the test is completed, administer an inhaled β-agonist to the patient [see Dosage and Administration (2.6)] . 10.Wash and clean reusable nebulizers thoroughly according to manufacturer’s recommendations and discard disposable nebulizers appropriately. 2.6 Recommended Administration of Inhaled β-agonist after Methacholine Challenge Test After the methacholine challenge test is completed, administer an inhaled β-agonist to the patient to expedite the return of the FEV1 to within 90% of baseline and to relieve any discomfort (the majority of patients revert to normal pulmonary function within 10 to 20 minutes after β-agonist administration; in contrast the majority of patients revert to normal pulmonary function within 30-45 minutes without β-agonist administration). Wait 10 minutes and measure the FEV1 and Vital Capacity. Do not allow patients to leave the laboratory or clinic until their FEV1 has returned to within 90% of baseline. 2.7 Interpretation of Methacholine Challenge Test Results and Calculation of Airway Hyperresponsiveness Positive Methacholine Challenge Test A positive methacholine challenge test is a ≥ 20% reduction in the FEV1 (after Provocholine oral inhalation) compared to the mean post-diluent FEV1. The test should be stopped at this point. Record the post-diluent FEV1 value and calculate the ≥ 20% FEV1 reduction value before starting the methacholine challenge test. If asthma drugs are discontinued prior to the methacholine challenge test, consider the possibility of rebound airway hyperreactivity in the interpretation of the test results. The methacholine challenge test may occasionally be falsely positive after an influenza infection or upper respiratory infection, immunizations, in very young or very old patients, in patients with chronic lung disease (e.g. cystic fibrosis, sarcoidosis, tuberculosis, chronic obstructive pulmonary disease), in patients with allergic rhinitis without asthma symptoms, in smokers, or in patients after exposure to air pollutants. If the 5-breath dosimeter dosing method is used, calculate airway hyperresponsiveness (PC20) based on the provocative Provocholine strength (mg/mL) that results in a fall in FEV1 of ≥ 20%. If the 1-minute tidal breathing dosing method is used, calculate airway hyperresponsiveness (PD20) based on the provocative Provocholine dose (mcg) that results in a fall in FEV1 of ≥ 20%. Calculation of PC 20 (5-breath dosimeter dosing method) 1. Determine the percent decrease [was fall] in FEV1 using the mean post-diluent FEV 1 and the lowest FEV 1 post-Provocholine (post-dose), as shown below: : % fall in FEV 1 = mean post-diluent FEV 1 - lowest FEV 1 post-Provocholine x 100 mean post-diluent FEV 1 2. Calculate PC 20 using one of the following methods: Method #1: Plot the percent decrease in FEV 1 against the increasing methacholine concentration using a log scale and obtain the PC 20 by linear interpolation between the last two points, as shown in Figure 1. Method #2: Calculate the PC 20 using the following equation: PC 20 = antilog [log C1+ (log C2 - log C1)(20 - R1) ] (R2- R1) Where: • C1 = second last methacholine concentration (< 20% FEV 1 decrease) • C2 = last methacholine concentration (≥ 20% FEV 1 decrease) • R1 = % fall FEV 1 after C1 • R2 = % fall FEV 1 after C2 Calculation of PD 20 (1-minute tidal breathing dosing method) Calculate the PD 20 as follows: PD 20 = antilog [log D1+ (log D2 - log D1)(20 - R1) ] (R2- R1) Where: • D1 = second last Provocholine dose (< 20% FEV 1 decrease) • D2 = last Provocholine dose (≥ 20% FEV 1 decrease) • R1 = % FEV 1 decrease after D1 • R2 = % FEV 1 decrease after D2 Negative Methacholine Challenge Test A negative (normal) methacholine challenge result is defined as FEV 1 reduction of < 20% after all the doses, as part of the dose doubling or quadrupling protocol in Table 5, have been administered [ See Dosage and Administration (2.3)] Graph

4 CONTRAINDICATIONS Provocholine is contraindicated in patients with: Hypersensitivity to methacholine or other parasympathomimetic agents. Reactions have included rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Baseline FEV 1 < 60% predicted (adults or pediatric patients) or <1.5 L (adults) hypersensitivity to methacholine chloride or other parasympathomimetic agents (4) Baseline FEV 1 <60% predicted (adults or pediatric patients) or <1.5 L (adults) (4)

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Provocholine were identified in clinical studies or post marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Respiratory System: Bronchospasm (includes symptoms such as chest tightness, cough or wheezing). Less Common Adverse Reactions: Headache, throat irritation, light-headedness and itching. Adverse reactions are bronchoconstriction, headache, throat irritation, light-headedness, and itching (6) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm at 1-866-701-4636 or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Provocholine used for?
1 INDICATIONS AND USAGE Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. Provocholine, a cholinergic agonist used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in …

Who makes Provocholine?
Methapharm Inc. is the labeler of record for Provocholine.

What form does Provocholine come in?
administered by respiratory (inhalation). Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Provocholine prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Provocholine been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.