| 00006ebc-ec2b-406c-96b7-a3cc422e933f |
| ACTIVE INGREDIENTS MEZEREUM |
| 00011703-bc55-4c0c-858c-149dc674bc3c | ADVERSE REACTIONS Ophthalmic use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, ch... | Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies to determine the carcinogenic potential of ofloxacin have not been conducted. Ofloxacin was not mutagenic in the Ames test, in v... | CLINICAL PHARMACOLOGY Pharmacokinetics: Serum, urine and tear concentrations of ofloxacin were measured in 30 healthy women at various time points during a ten-day course of treatment with ofloxacin o... | Clinical Studies: Conjunctivitis: In a randomized, double-masked, multi-center clinical trial, ofloxacin ophthalmic solution was superior to its vehicle after 2 days of treatment in patients with conj... | CONTRAINDICATIONS Ofloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication (see... |
| 000155a8-709c-44e5-a75f-cd890f3a7caf | 6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] • GI ... | ANDA078250 | WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular t... | Naproxen | 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A 2-year study was performed in rats to evaluate the carcinogenic potential of naproxen at rat doses of 8, 16, and 24 mg/kg/day... | 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Naproxen has analgesic, anti-inflammatory, and antipyretic properties. Naproxen sodium has been developed as a more rapidly absorbed formulation of na... | 14 CLINICAL STUDIES Naproxen has been studied in patients with rheumatoid arthritis, osteoarthritis, polyarticular juvenile idiopathic arthritis, ankylosing spondylitis, tendonitis and bursitis, and a... | 4 CONTRAINDICATIONS Naproxen tablets and naproxen sodium tablets are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to na... |
| 00018a89-9260-459b-86d3-c58a9bb899ea | Active ingredient Chlorhexidine Gluconate 4% Solution |
| 0001d1cf-f727-4875-a44f-5a51f7b617a4 | Active ingredient Benzalkonium chloride 0.13% | 505G(a)(3) | Moisturizing Antibacterial |
| 0001eaa9-e890-4e94-9d44-47a0f3086a02 | Active Ingredient....................................Purpose Sulphur 5%...............................................Acne medication Benzoyl Peroxide 2.5%...............................Acme medicatio... |
| 00023ca2-4433-4f88-8252-bc8c1d7ea2e0 | Active Ingredient (In Each Bottle)---Pseudoephedrine HCl 60 mg |
| 00025ea5-d15f-49d2-a52a-6c1bd8c6a033 | Active ingredient Salicylic acid 2% | ADVERSE REACTION Information: 1-888-287-1915 or Walmart.com/help DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 PLASTIC TUBE Do Not Recycle how2recycle.info Made in the USA with domestic and impo... | M006 | Quick Action |
| 0002a6ef-6e5e-4a34-95d5-ebaab222496f | Active Ingredients: Cuprum aceticum (Copper acetate) 6X, Lobelia 6X, Renes (Bovine kidneys) 6X, Nicotiana (Tobacco) 10X, Arsenicum album (White arsenic) 12X |
| 0002ad27-779d-42ab-83b5-bc65453412a1 | 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: New Primary Malignancies [see Warnings and Precautions ( 5.1)] Hemorrhage [see Warni... | NDA204114, NDA217513 | Mekinist | 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with trametinib have not been conducted. Trametinib was not genotoxic in studies evaluating reverse mutations in bacte... | 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Trametinib is a reversible inhibitor of mitogen-activated extracellular signal-regulated kinase 1 (MEK1) and MEK2 activation and of MEK1 and MEK2 kina... | 14 CLINICAL STUDIES Figure 1. Kaplan-Meier Curves of Investigator-Assessed Progression-Free Survival (ITT Population) in the METRIC Study Figure 2. Kaplan-Meier Curves of Overall Survival in the COMBI... | 4 CONTRAINDICATIONS None. None. ( 4 ) |
| 0002eded-a283-4590-a78c-b6ff2027e684 | ADVERSE REACTIONS Postherpetic Neuralgia The most commonly observed adverse events associated with the use of gabapentin in adults, not seen at an equivalent frequency among placebo-treated patients, ... | Carcinogenesis, Mutagenesis, Impairment of Fertility Gabapentin was given in the diet to mice at 200, 600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for 2 years. A statistically ... | CLINICAL PHARMACOLOGY Mechanism of Action The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behav... | Clinical Studies | CONTRAINDICATIONS Gabapentin tablets USP are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. |
| 0003458f-352a-46fa-9d99-230daa76ae29 | 6 ADVERSE REACTIONS The following serious adverse reactions are discussed in more detail below and elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1) ] Hemolytic anemia [see W... | ANDA077091 | Glimepiride | 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Studies in rats at doses of up to 5000 parts per million (ppm) in complete feed (approximately 340 times the maximum recommended human dose, b... | 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Glimepiride primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells. Sulfonylureas bind to the sulfonylurea re... | 14 CLINICAL STUDIES 14.1 Monotherapy A total of 304 patients with type 2 diabetes already treated with sulfonylurea therapy participated in a 14-week, multicenter, randomized, double-blind, placebo-co... | 4 CONTRAINDICATIONS Glimepiride tablets are contraindicated in patients with a history of a hypersensitivity reaction to: Glimepiride or any of the product’s ingredients [see Warnings and Precautions ... |
| 00038c95-b2c8-4245-b671-6af177b3a00e | ADVERSE REACTIONS The majority of side effects observed in clinical trials were of a mild and transient nature. Fewer than 3% of adult patients without mycobacterial infections and fewer than 2% of pe... | Note: When testing Streptococcus pyogenes and Streptococcus pneumoniae , susceptibility and resistance to clarithromycin can be predicted using erythromycin., Note: When testing Streptococcus pyogenes and Streptococcus pneumoniae , susceptibility and resistance to clarithromycin can be predicted using erythromycin. | Carcinogenesis, Mutagenesis, Impairment of Fertility The following in vitro mutagenicity tests have been conducted with clarithromycin: Salmonella /Mammalian Microsomes Test Bacterial Induced Mutation... | CLINICAL PHARMACOLOGY Pharmacokinetics Clarithromycin is rapidly absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability of 250 mg clarithromycin tablets was a... | CLINICAL STUDIES Mycobacterial Infections Prophylaxis A randomized, double-blind study (561) compared clarithromycin 500 mg b.i.d. to placebo in patients with CDC-defined AIDS and CD 4 counts <100 cel... | CONTRAINDICATIONS Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics. Clarithromy... |
| 0003eccd-6147-4a7c-ae83-b2a94933e07d | ADVERSE REACTIONS Adverse reactions reported coincident with the administration of methocarbamol include: Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular sy... | ANDA086988 | Methocarbamol | Carcinogenesis, mutagenesis, impairment of fertility Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the eff... | CLINICAL PHARMACOLOGY The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the con... | CONTRAINDICATIONS Methocarbamol tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components. |
| 00040bfe-001a-484e-bec0-e21e8b27f369 | Active ingredient Hydrocortisone 1% | M017 | anti itch |
| 00046231-8fab-44a0-b986-9a9dd450881d | ADVERSE REACTIONS Adverse reactions other than those indicative of hyperthyroidism because of therapeutic overdosage, either initially or during the maintenance period, are rare (See OVERDOSAGE). | Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requi... | NP Thyroid 120 | Carcinogenesis, Mutagenesis, and Impairment of Fertility — A reportedly apparent association between prolonged thyroid therapy and breast cancer has not been confirmed and patients on thyroid for esta... | CLINICAL PHARMACOLOGY The steps in the synthesis of the thyroid hormones are controlled by thyrotropin (Thyroid Stimulating Hormone, TSH) secreted by the anterior pituitary. This hormone’s secretion i... | CONTRAINDICATIONS Thyroid hormone preparations are generally contraindicated in patients with diagnosed but as yet uncorrected adrenal cortical insufficiency, untreated thyrotoxicosis, and apparent hy... |
| 0004a0bb-87c0-46f8-b36a-95c98107395d | 6 ADVERSE REACTIONS The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling: Neuropsychiatric Adverse Ev... | ANDA214595 | Varenicline | 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Lifetime carcinogenicity studies were performed in CD-1 mice and Sprague-Dawley rats. There was no evidence of a carcinogenic e... | 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Varenicline binds with high affinity and selectivity at α4β2 neuronal nicotinic acetylcholine receptors. The efficacy of varenicline in smoking cessat... | 14 CLINICAL STUDIES The efficacy of varenicline in smoking cessation was demonstrated in six clinical trials in which a total of 3659 chronic cigarette smokers (≥10 cigarettes per day) were treated wi... | 4 CONTRAINDICATIONS Varenicline tablets are contraindicated in patients with a known history of serious hypersensitivity reactions or skin reactions to varenicline tablets. History of serious hypersen... |
| 000506eb-0340-4d15-9dd1-71f10c83a3b9 | Active ingredients Chlorhexidine gluconate 2% w/v Isopropyl alcohol 70% v/v |
| 00051a01-1c2e-4abb-b04c-548401f822c6 | Active ingredient (in each capsule) Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)* *nonsteroidal anti-inflammatory drug |
| 00052c1a-9e0f-44ba-bc93-025add5a4031 | Active ingredients Each 5X (HPUS) Purpose White Chestnut (Aesculus hippocastanum) Relief from repetitive thoughts Rock Rose (Helianthemum nummularium) Courage and presence of mind Clematis (Clematis v... | Rescue Sleep |
| 0005aafa-08f8-4990-a54d-cc097195708f | Active ingredient (in each gelcap) Acetaminophen 500 mg | M013 | Pain Reliever Extra Strength |
| 0005c982-7906-418a-979b-83da67566e96 | ACTIVE INGREDIENTS TITANIUM DIOXIDE 11,52% |
SPL Set ID | Active Ingredient | Adverse Reactions | Application Numbers | Boxed Warning | Brand Names | Carcinogenesis, Mutagenesis, Impairment of Fertility | Clinical Pharmacology | Clinical Studies | Contraindications | Dependence | Description | Do Not Use | Dosage and Administration | Dosage and Administration Table | Drug Abuse and Dependence | Drug and Laboratory Test Interactions | Drug Interactions | Effective Time | Generic Names | Geriatric Use | How Supplied | Inactive Ingredient | Indications and Usage | Information for Patients | Is Original Packager | Keep Out of Reach of Children | Labor and Delivery | Manufacturer Names | Mechanism of Action | Nursing Mothers | OpenFDA SPL IDs | OpenFDA SPL Set IDs | Overdosage | Package Label Principal Display Panel | Package NDCs | Pediatric Use | Precautions | Pregnancy | Pregnancy or Breast Feeding | Product NDCs | Product Type | Purpose | Questions | References | Routes | RxCUIs | SPL ID | SPL Medguide | SPL Medguide Table | SPL Product Data Elements | Stop Use | Storage and Handling | Substance Names | UNIIs | UPCs | Use in Specific Populations | Version | Warnings | Warnings and Cautions |
|---|