Lisinopril (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Lisinopril Tablets, USP 40 mg are supplied as follows:

40 mg Tablets: Yellow, round, unscored, flat-faced, beveled-edge tablets, debossed “ WATSON ” and “ 409 ” on the periphery of one side and plain on the other side, in bottles of 90 NDC 51655-292-26 and in bottles of 30 NDC 51655-292-52

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from moisture, freezing and excessive heat. Dispense in a tight container as defined in the USP.

17 PATIENT COUNSELING INFORMATION

NOTE: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Pregnancy: Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to notify their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations ( 8.1)].

Angioedema: Angioedema, including laryngeal edema may occur at any time during treatment with angiotensin converting enzyme inhibitors, including lisinopril. Tell patients to report immediately any signs or symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in swallowing or breathing) and to take no more drug until they have consulted with the prescribing physician.

Lactation: Advise women not to breastfeed during treatment with lisinopril [see Use in Specific Populations ( 8.2)].

Symptomatic Hypotension: Tell patients to report light-headedness especially during the first few days of therapy. If actual syncope occurs, tell the patient to discontinue the drug until they have consulted with the prescribing physician.

Tell patients that excessive perspiration and dehydration may lead to an excessive fall in blood pressure because of reduction in fluid volume. Other causes of volume depletion such as vomiting or diarrhea may also lead to a fall in blood pressure; advise patients accordingly.

Hyperkalemia: Tell patients not to use salt substitutes containing potassium without consulting their physician. Hypoglycemia: Tell diabetic patients treated with oral antidiabetic agents or insulin starting an ACE inhibitor to monitor for hypoglycemia closely, especially during the first month of combined use [see Drug Interactions ( 7.2)].

Leukopenia/Neutropenia: Tell patients to report promptly any indication of infection (e.g., sore throat, fever), which may be a sign of leukopenia/neutropenia.

Brands listed are trademarks of their respective owners.

Manufactured by:
Watson Pharma Private Limited
Verna, Salcette Goa 403 722 INDIA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised: November 2017

Principal Display Panel

NDC: 51655-292-26

Label
(click image for full-size original)
LISINOPRIL
lisinopril tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-292(NDC:0591-0409)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL ANHYDROUS) LISINOPRIL 40 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C YELLOW NO. 5
MAGNESIUM STEARATE
MANNITOL
STARCH, CORN
Product Characteristics
Color yellow Score no score
Shape ROUND Size 10mm
Flavor Imprint Code WATSON;409
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-292-26 90 TABLET in 1 BOTTLE, DISPENSING None
2 NDC:51655-292-52 30 TABLET in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076059 03/10/2015
Labeler — Northwind Pharmaceuticals (036986393)
Registrant — Northwind Pharmaceuticals (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals 036986393 repack (51655-292)
Establishment
Name Address ID/FEI Operations
EPM Packaging Inc. 079124340 repack (51655-292)

Revised: 12/2021 Northwind Pharmaceuticals

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