Felodipine Tablet, Film Coated
Product Images NDC 72162-1742
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This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Felodipine (NDC 72162-1742). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Bryant Ranch Prepack, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
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Label (Lbl721621742)
Felodipine Extended-Release Tablets, USP are a medication that contains 2.5mg of Felodipine. These tablets are to be taken orally and should be swallowed whole, without being crushed, cut, or chewed. They are available in a container that is tightly closed and resistant to light. The tablets should be stored at a temperature between 20°C and 25°C (68°F and 77°F). This medication is only to be dispensed by a pharmacist, and the instructions for use can be found at the provided website. The manufacturer of these tablets is Yung Shin Pharmaceutical Ind. Co., Ltd, and they were relabeled by Bryant Ranch Prepack, Inc.*
Table 1 (Table 1)
Table 2 (Table 2)
Percent of Patients with Adverse Events in Controlled Trials" of Felodipine Extended-Release Tablets (N = 861) as Monotherapy without Regard to Causality (Incidence of discontinuations shown in parentheses)
Body System:
- Peripheral Edema: 33% in placebo group, 2% in 25mg group, 88% in 5mg group, 174% in 10mg group
- Asthenia: 33% in placebo group, 39% in 25mg group, 33000% in 5mg group, 22% in 10mg group
- Warm Sensation: 0% in placebo group, 0% in 25mg group, 09% in 5mg group, 15% in 10mg group
- Palpitation: 24% in placebo group, 04% in 25mg group, 14% in 5mg group, 25% in 10mg group
- Nausea: 15% in placebo group, 12% in 25mg group, 17% in 5mg group, 1% in 10mg group
- Dyspepsia: 12% in placebo group, 39% in 25mg group, 07% in 5mg group, 05% in 10mg group
- Constipation: 09% in placebo group, 12% in 25mg group, 03% in 5mg group, 15% in 10mg group
- Headache: 102% in placebo group, 106% in 25mg group, 11% in 5mg group, 147% in 10mg group
- Dizziness: 27% in placebo group, 27% in 25mg group, 36% in 5mg group, 37% in 10mg group
- Paresthesia: 15% in placebo group, 16% in 25mg group, 12000% in 5mg group, 12002% in 10mg group
- Upper Respiratory Infection: 1.8% in placebo group, 39% in 25mg group, 19000% in 5mg group, 07% in 10mg group
- Cough: 03% in placebo group, 08% in 25mg group, 12000% in 5mg group, 17% in 10mg group
- Rhinorthea: 0% in placebo group, 16% in 25mg group, 02% in 5mg group, 02% in 10mg group
- Sneezing: 0% in placebo group, 16% in 25mg group, 0% in 5mg group, 0% in 10mg group
- Rash: 09% in placebo group, 2% in 25mg group, 02% in 5mg group, 02% in 10mg group
- Flushing: 09% in placebo group, 39% in 25mg group, 53% in 5mg group, 69% in 10mg group
Note: Patients in titration studies may have been exposed to more than one dose level of felodipine extended-release tablets.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.