16 HOW SUPPLIED/STORAGE AND HANDLING
Ramipril Capsules USP, 1.25 mg are yellow/yellow size ‘4’ hard gelatin capsules imprinted with ‘D’ on yellow cap and ‘05’ on yellow body with black edible ink filled with white to almost white powder.
Bottles of 100 NDC 68001-428-00
Ramipril Capsules USP, 2.5 mg are orange/orange size ‘4’ hard gelatin capsules imprinted with ‘D’ on orange cap and ‘06’ on orange body with black edible ink filled with white to almost white powder.
Bottles of 100 NDC 68001-429-00
Ramipril Capsules USP, 5 mg are red/red size ‘4’ hard gelatin capsules imprinted with ‘D’ on red cap and ‘07’ on red body with black edible ink filled with white to almost white powder.
Bottles of 100 NDC 68001-430-00
Bottles of 500 NDC 68001-430-03
Ramipril Capsules USP, 10 mg are blue/blue size ‘4’ hard gelatin capsules imprinted with ‘D’ on blue cap and ‘08’ on blue body with black edible ink filled with white to almost white powder.
Bottles of 100 NDC 68001-431-00
Bottles of 500 NDC 68001-431-03
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Dispense in well-closed container with safety closure.
17 PATIENT COUNSELING INFORMATION
Angioedema
Angioedema, including laryngeal edema, can occur with treatment with ACE inhibitors, especially following the first dose. Advise patients to immediately report any signs or symptoms suggesting angioedema (swelling of face, eyes, lips, or tongue, or difficulty in breathing) and to temporarily discontinue drug until they have consulted with the prescribing physician.
Neutropenia
Advise patients to promptly report any indication of infection (e.g., sore throat, fever), which could be a sign of neutropenia.
Symptomatic Hypotension
Inform patients that light-headedness can occur, especially during the first days of therapy, and it should be reported. Advise patients to discontinue ramipril if syncope (fainting) occurs, and to follow up with their health care providers.
Inform patients that inadequate fluid intake or excessive perspiration, diarrhea, or vomiting while taking ramipril can lead to an excessive fall in blood pressure, with the same consequences of lightheadedness and possible syncope.
Pregnancy
Tell female patients of childbearing age about the consequences of exposure to ramipril during pregnancy. Discuss treatment options with women planning to become pregnant. Ask patients to report pregnancies to their physicians as soon as possible.
Hyperkalemia
Advise patients not to use salt substitutes containing potassium without consulting their physician.
Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 090, India
For BluePoint Laboratories
M.L No.: 19/ HD/ AP/ 95/ F/ R
Revised: 08/2021
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1.25 mg (100 Capsule Bottle)
NDC 68001-428-00
Rx only
Ramipril Capsules, USP
1.25 mg BluePoint Laboratories 100 Capsules
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2.5 mg (100 Capsule Bottle)
NDC 68001-429-00
Rx only
Ramipril Capsules, USP
2.5 mg BluePoint Laboratories 100 Capsules
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (100 Capsule Bottle)
NDC 68001-430-00
Rx only
Ramipril Capsules, USP
5 mg BluePoint Laboratories 100 Capsules
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (100 Capsule Bottle)
NDC 68001-431-00
Rx only
Ramipril Capsules, USP
10 mg BluePoint Laboratories 100 Capsules
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Revised: 09/2021 BluePoint Laboratories
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/ramipril-39/page/7/