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Sulfa Side Effects

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Common Sulfa Side Effects


The most commonly reported Sulfa side effects (click to view or check a box to report):

Rash (222)
Pyrexia (220)
Renal Failure Acute (182)
Nausea (167)
Headache (135)
Hyperkalaemia (115)
Pruritus (107)
Vomiting (103)
Stevens-johnson Syndrome (98)
Fatigue (94)
Dyspnoea (93)
Asthenia (92)
Diarrhoea (91)
Pain (83)
Urticaria (79)
Chills (73)
Arthralgia (72)
Malaise (68)
Hypersensitivity (66)
Neutropenia (63)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Sulfa Side Effects Reported to FDA



Sulfa Side Effect Report#9999812
Rash, Liver Function Test Abnormal, Neutropenic Sepsis, Hepatitis
This is a report of a 40-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Sulfasalazine (dosage: NA, start time: NS), combined with:
  • 6-mercaptopurine (Unk)
  • Pentasa (Unk)
  • Co-codamol (Unk)
  • Difflam (Unk (spray))
  • Penicillin V (Unk)
and developed a serious reaction and side effect(s): Rash, Liver Function Test Abnormal, Neutropenic Sepsis, Hepatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in male patients, resulting in Rash side effect. The patient was hospitalized.
Sulfa Side Effect Report#9999560
Renal Failure, Hyperkalaemia
This report suggests a potential Sulfamethoxazole/trimethoprim Renal Failure side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Sulfamethoxazole/trimethoprim (dosage: NA) starting
Jul 01, 2013. After starting Sulfamethoxazole/trimethoprim the patient began experiencing various side effects, including: Renal Failure, HyperkalaemiaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Sulfamethoxazole/trimethoprim demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Failure, may still occur.
Sulfa Side Effect Report#9994560
Pulmonary Embolism
This Pulmonary Embolism problem was reported by a pharmacist from GB. A 42-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis reactive. On
Jan 01, 1990 this consumer started treatment with Sulfasalazine (dosage: 1 G, 2x/day). The following drugs were being taken at the same time:
  • Tinzaparin (Unk)
  • Warfarin (Unk)
When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Pulmonary EmbolismThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Embolism, may become evident only after a product is in use by the general population.
Sulfa Side Effect Report#9981631
Stevens-johnson Syndrome, Toxic Epidermal Necrolysis, Rash
This Stevens-johnson Syndrome side effect was reported by a pharmacist from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: infection.The patient was prescribed Sulfamethoxazole/trimethoprim 800 Mg/160 (drug dosage: 1 Bid Oral), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sulfamethoxazole/trimethoprim 800 Mg/160 the consumer reported adverse symptoms, such as: Stevens-johnson Syndrome, Toxic Epidermal Necrolysis, RashThese side effects may potentially be related to Sulfamethoxazole/trimethoprim 800 Mg/160.
Sulfa Side Effect Report#9981621
Stevens-johnson Syndrome, Wound
This is a report of a 34-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: cellulitis, who was treated with Sulfamethoxazole/trimethoprim (dosage: NA, start time:
Mar 02, 2014), combined with: NA. and developed a serious reaction and side effect(s): Stevens-johnson Syndrome, Wound after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in Stevens-johnson Syndrome side effect. The patient was hospitalized.
Sulfa Side Effect Report#9973013
Lupus-like Syndrome, Cerebral Infarction
This report suggests a potential Sulfasalazine Lupus-like Syndrome side effect(s) that can have serious consequences. A 19-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: colitis ulcerative and used Sulfasalazine (dosage: 1.5 G, Daily) starting NS. After starting Sulfasalazine the patient began experiencing various side effects, including: Lupus-like Syndrome, Cerebral InfarctionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Sulfasalazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lupus-like Syndrome, may still occur.
Sulfa Side Effect Report#9973012
Cerebral Infarction, Hemiparesis, Hypersensitivity, Headache, Pyrexia
This Cerebral Infarction problem was reported by a physician from US. A 13-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: crohn^s disease. On NS this consumer started treatment with Sulfasalazine (dosage: 1.5 G, Daily). The following drugs were being taken at the same time: NA. When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Cerebral Infarction, Hemiparesis, Hypersensitivity, Headache, PyrexiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cerebral Infarction, may become evident only after a product is in use by the general population.
Sulfa Side Effect Report#9973001
Ataxia, Peripheral Sensory Neuropathy, Neurotoxicity
This Ataxia side effect was reported by a physician from US. A 73-year-old male patient (weight:NA) experienced the following symptoms/conditions: colitis ulcerative.The patient was prescribed Sulfasalazine (drug dosage: 3 G, Daily), which was initiated on NS. Concurrently used drugs:
  • Prednisone (Unk)
.After starting to take Sulfasalazine the consumer reported adverse symptoms, such as: Ataxia, Peripheral Sensory Neuropathy, NeurotoxicityThese side effects may potentially be related to Sulfasalazine. The patient was hospitalized.
Sulfa Side Effect Report#9972998
Peripheral Sensorimotor Neuropathy, Paraparesis, Paraesthesia, Muscular Weakness, Ataxia
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: colitis ulcerative, who was treated with Sulfasalazine (dosage: 1 G, 1x/day, start time: NS), combined with:
  • Prednisolone (60 Mg, Alternate Day)
  • Prednisolone (15 Mg, Alternate Day)
  • Prednisolone (10 Mg, Alternate Day)
  • Prednisolone (7.5 Mg, Alternate Day)
  • Prednisolone (Unk)
  • Ferrous Sulphate (Unk)
and developed a serious reaction and side effect(s): Peripheral Sensorimotor Neuropathy, Paraparesis, Paraesthesia, Muscular Weakness, Ataxia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in female patients, resulting in Peripheral Sensorimotor Neuropathy side effect. The patient was hospitalized.
Sulfa Side Effect Report#9972324
Hyponatraemia, Hypokalaemia
This report suggests a potential Sulfamethoxazole-trimethoprim, Ds Hyponatraemia side effect(s) that can have serious consequences. A 57-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pneumocystis jirovecii pneumonia and used Sulfamethoxazole-trimethoprim, Ds (dosage: NA) starting NS. After starting Sulfamethoxazole-trimethoprim, Ds the patient began experiencing various side effects, including: Hyponatraemia, HypokalaemiaAdditional drugs used concurrently:
  • Acetaminophen
  • Azithromycin
  • Budesonide
  • Dextrose
  • Emtricitabine/tenofovir
  • Etravirine
  • Heparin
  • Ipratropium/albuterol
The patient was hospitalized. Although Sulfamethoxazole-trimethoprim, Ds demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hyponatraemia, may still occur.
Sulfa Side Effect Report#9972312
Leukoplakia Oral, Glossitis, Stomatitis
This Leukoplakia Oral problem was reported by a consumer or non-health professional from DE. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: rheumatic disorder. On 2009 this consumer started treatment with Sulfasalazine (dosage: Unk). The following drugs were being taken at the same time: NA. When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Leukoplakia Oral, Glossitis, StomatitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Leukoplakia Oral, may become evident only after a product is in use by the general population.
Sulfa Side Effect Report#9970468
Pharyngitis, Dysphagia, Odynophagia, Dysphonia, Oral Candidiasis, Agranulocytosis
This Pharyngitis side effect was reported by a consumer or non-health professional from US. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: furuncle.The patient was prescribed Sulfamethoxazole And Trimethorpim (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sulfamethoxazole And Trimethorpim the consumer reported adverse symptoms, such as: Pharyngitis, Dysphagia, Odynophagia, Dysphonia, Oral Candidiasis, AgranulocytosisThese side effects may potentially be related to Sulfamethoxazole And Trimethorpim. The patient was hospitalized.
Sulfa Side Effect Report#9961554
Nausea, Vomiting, Hyperkalaemia, Bradycardia, Dialysis
This is a report of a 66-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: urinary tract infection,hypertension, who was treated with Sulfamethoxazole/trimethoprim (dosage: NA, start time:
May 12, 2010), combined with:
  • Spironolactone
and developed a serious reaction and side effect(s): Nausea, Vomiting, Hyperkalaemia, Bradycardia, Dialysis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazole/trimethoprim treatment in male patients, resulting in Nausea side effect. The patient was hospitalized.
Sulfa Side Effect Report#9954451
Oral Mucosal Discolouration, Paraesthesia Oral, Lip Swelling
This report suggests a potential Sulfamethoxazole/trimethoprim Tablets Oral Mucosal Discolouration side effect(s) that can have serious consequences. A 35-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Sulfamethoxazole/trimethoprim Tablets (dosage: 800 Mg/160 Mg) starting 201303. After starting Sulfamethoxazole/trimethoprim Tablets the patient began experiencing various side effects, including: Oral Mucosal Discolouration, Paraesthesia Oral, Lip SwellingAdditional drugs used concurrently: NA. Although Sulfamethoxazole/trimethoprim Tablets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oral Mucosal Discolouration, may still occur.
Sulfa Side Effect Report#9937218
Hepatic Necrosis
This Hepatic Necrosis problem was reported by a health professional from FR. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: cerebral toxoplasmosis,acquired immunodeficiency syndrome. On NS this consumer started treatment with Sulfadiazine (dosage: NA). The following drugs were being taken at the same time: NA. When using Sulfadiazine, the patient experienced the following unwanted symptoms/side effects: Hepatic NecrosisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hepatic Necrosis, may become evident only after a product is in use by the general population.
Sulfa Side Effect Report#9924832
Palpitations, Dizziness, Dyspnoea, Penile Blister, Burns Second Degree
This Palpitations side effect was reported by a consumer or non-health professional from US. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: sinusitis.The patient was prescribed Sulfamethoxazole/trimethoprim 800/160 (drug dosage: One Table Twice Daily), which was initiated on
Feb 13, 2014. Concurrently used drugs: NA..After starting to take Sulfamethoxazole/trimethoprim 800/160 the consumer reported adverse symptoms, such as: Palpitations, Dizziness, Dyspnoea, Penile Blister, Burns Second DegreeThese side effects may potentially be related to Sulfamethoxazole/trimethoprim 800/160.
Sulfa Side Effect Report#9922824
Meningitis Aseptic, Pain In Extremity, Hypersensitivity, Rash Macular
This is a report of a 37-year-old female patient (weight: NA) from TN, suffering from the following health symptoms/conditions: arthritis, who was treated with Sulfasalazine (dosage: 0.5 G, Daily, start time: 1989), combined with: NA. and developed a serious reaction and side effect(s): Meningitis Aseptic, Pain In Extremity, Hypersensitivity, Rash Macular after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in female patients, resulting in Meningitis Aseptic side effect. The patient was hospitalized.
Sulfa Side Effect Report#9922318
Activities Of Daily Living Impaired, Interstitial Lung Disease, Gait Disturbance
This report suggests a potential Sulfasalazine Activities Of Daily Living Impaired side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: colitis and used Sulfasalazine (dosage: 2 Tablets 4 Times A Day By Mouth) starting 1980. After starting Sulfasalazine the patient began experiencing various side effects, including: Activities Of Daily Living Impaired, Interstitial Lung Disease, Gait DisturbanceAdditional drugs used concurrently:
  • Omeprazole
  • Potassium
  • Loprazolam
  • Simvastatin
  • Setraline
  • Furosemide
  • Fish Oil
Although Sulfasalazine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Activities Of Daily Living Impaired, may still occur.
Sulfa Side Effect Report#9921705
Meningitis Aseptic, Hypersensitivity, Rash Maculo-papular, Transaminases Increased, Oedema
This Meningitis Aseptic problem was reported by a health professional from TN. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: synovitis. On NS this consumer started treatment with Sulfasalazine (dosage: 500 Mg, Daily). The following drugs were being taken at the same time: NA. When using Sulfasalazine, the patient experienced the following unwanted symptoms/side effects: Meningitis Aseptic, Hypersensitivity, Rash Maculo-papular, Transaminases Increased, OedemaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Meningitis Aseptic, may become evident only after a product is in use by the general population.
Sulfa Side Effect Report#9921699
Meningitis Aseptic
This Meningitis Aseptic side effect was reported by a health professional from TN. A 41-year-old male patient (weight:NA) experienced the following symptoms/conditions: rheumatoid arthritis.The patient was prescribed Sulfasalazine (drug dosage: 500 Mg, 2x/day), which was initiated on NS. Concurrently used drugs:
  • Prednisone (10 Mg, Daily)
.After starting to take Sulfasalazine the consumer reported adverse symptoms, such as: Meningitis AsepticThese side effects may potentially be related to Sulfasalazine. The patient was hospitalized.
Sulfa Side Effect Report#9921694
Meningitis Aseptic
This is a report of a 34-year-old female patient (weight: NA) from TN, suffering from the following health symptoms/conditions: ankylosing spondylitis, who was treated with Sulfasalazine (dosage: 2 G, Daily, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Meningitis Aseptic after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfasalazine treatment in female patients, resulting in Meningitis Aseptic side effect. The patient was hospitalized.
Sulfa Side Effect Report#9921286
Candida Infection, Agranulocytosis
This report suggests a potential Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg Candida Infection side effect(s) that can have serious consequences. A 68-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: antibiotic prophylaxis and used Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg (dosage: NA) starting NS. After starting Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg the patient began experiencing various side effects, including: Candida Infection, AgranulocytosisAdditional drugs used concurrently: NA. Although Sulfamethoxazole And Trimethoprim Tablets, Usp 800 Mg/ 160 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Candida Infection, may still occur.
Sulfa Side Effect Report#9913516
Renal Failure Acute, Hyperkalaemia
This Renal Failure Acute problem was reported by a consumer or non-health professional from US. A 94-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 15, 2001 this consumer started treatment with Sulfamethoxazole/trimethoprim (dosage: NA). The following drugs were being taken at the same time:
  • Lisinopril
When using Sulfamethoxazole/trimethoprim, the patient experienced the following unwanted symptoms/side effects: Renal Failure Acute, HyperkalaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Failure Acute, may become evident only after a product is in use by the general population.
Sulfa Side Effect Report#9912531
Hyperkalaemia
This Hyperkalaemia side effect was reported by a pharmacist from US. A 71-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Sulfamethoxazole/trimethoprim (drug dosage: NA), which was initiated on
Mar 11, 2013. Concurrently used drugs: NA..After starting to take Sulfamethoxazole/trimethoprim the consumer reported adverse symptoms, such as: HyperkalaemiaThese side effects may potentially be related to Sulfamethoxazole/trimethoprim. The patient was hospitalized.
Sulfa Side Effect Report#9909700
Nausea, Asthenia, Hunger, Vomiting, Dry Mouth
This is a report of a 31-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: urinary tract infection, who was treated with Sulfamethoxazol/trimethoprim (dosage: NA, start time:
Dec 07, 2013), combined with: NA. and developed a serious reaction and side effect(s): Nausea, Asthenia, Hunger, Vomiting, Dry Mouth after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sulfamethoxazol/trimethoprim treatment in female patients, resulting in Nausea side effect.


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The appearance of Sulfa on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.


What are common Sulfa Side Effects for Women?

Women Side EffectsReports
Pyrexia 122
Rash 95
Headache 86
Nausea 82
Pruritus 65
Pain 58
Vomiting 56
Dyspnoea 55
Fatigue 55
Diarrhoea 53

What are common Sulfa Side Effects for Men?

Men Side EffectsReports
Renal Failure Acute 163
Rash 126
Hyperkalaemia 110
Pyrexia 95
Nausea 85
Asthenia 53
Stevens-johnson Syndrome 52
Headache 49
Vomiting 47
Urticaria 44

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Sulfa reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    How Effective is Sulfa for You?

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    Sulfa Safety Alerts, Active Ingredients, Usage Information

    NDC0054-0235
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameMorphine Sulfate
    NameMorphine Sulfate
    Dosage FormTABLET
    RouteORAL
    On market since20080317
    LabelerRoxane Laboratories, Inc
    Active Ingredient(s)MORPHINE SULFATE
    Strength(s)15
    Unit(s)mg/1
    Pharma ClassFull Opioid Agonists [MoA],Opioid Agonist [EPC]

    More About Sulfa

    Side Effects reported to FDA: 2617

    Sulfa safety alerts: 2014 2012 2011 2010 2009 2008 2007 2006 2005 2003 2002 2000

    Reported deaths: 76

    Reported hospitalizations: 601

    Ferrous Sulfate Tablets, 325 mg Labeled as Rugby Natural Iron Supplement: Recall - Bottle May Contain Meclizine HCl 25 mg Tablets


    [Posted 01/18/2013]

    AUDIENCE: Pharmacy, Consumer

    ISSUE: Advance Pharmaceutical Inc. notified the public of a recall of one lot of Ferrous Sulfate Tablets 325 mg, after notification by a pharmacist that a bottle of Ferrous Sulfate Tablets, 325 mg contained Meclizine HCl 25 mg tablets. The lot of the Rugby Ferrous Sulfate is 12G468. Expiration date for the lot is 07/14. The lot was manufactured and packaged in 100 count bottles by Advance Pharmaceutical Inc. under the label of Rugby NATURAL IRON SUPPLEMENT Ferrous Sulfate -- see Product Photo page. Meclizine toxicity may lead to dose-related serious adverse events, including impaired alertness, drowsiness, confusion, low blood pressure, coma, and respiratory depression. Without supportive treatment meclizine toxicity has the potential to be life-threatening.

    BACKGROUND: Taking Meclizine HCl 25 mg as Ferrous Sulfate 325 mg may cause serious side effects to those who consume alcohol or other sedatives, those with a pre-existing CNS disorder, those with kidney or liver dysfunction, the elderly, nursing infants of lactating mothers who received the drug and newborns of mothers who received the drug immediately before childbirth.

    Consumers who take three tablets daily of the defective product for treatment of iron deficiency would be inadvertently ingesting 75 mg of meclizine HCl daily, which is close to the maximum daily adult dose in prescription meclizine drug products of 100 mg. Consumption of meclizine three times a day instead of once daily as monograph recommended is likely to lead to significant drug accumulation because it is a long-acting drug with effects that may persist up to 24 hours after a single dose.

    RECOMMENDATION: Consumers who have the affected lot should not take the product. They may contact Advance Pharmaceutical with questions at 631-981-4600, Ext.300, Monday through Friday between 8:30 am and 4:30 pm ET.


    [01/17/2013 - Press Release - Advance Pharmaceutical]
    [01/17/2013 - Product Photos - FDA]

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