Pyridostigmine Bromide (Page 2 of 2)

REFERENCES:

1.
Osserman KE, Genkins G. Studies in myasthenia gravis: Reduction in mortality rate after crisis. JAMA. Jan 1963; 183:97-101.
2.
Osserman KE, Genkins G. Studies in myasthenia gravis. NY State J Med. June 1961; 61:2076-2085.
3.
Grob D. Myasthenia gravis. A review of pathogenesis and treatment. Arch Intern Med. Oct 1961; 108:615-638.
4.
Schwab RS. Management of myasthenia gravis. New Eng J Med. Mar 1963; 268:596-597.
5.
Schwab RS. Management of myasthenia gravis. New Eng J Med. Mar 1963; 268:717-719.
6.
Cronnelly R, Stanski DR, Miller RD, Sheiner LB. Pyridostigmine kinetics with and without renal function. Clin Pharmacol Ther. 1980; 28: No. 1, 78-81.
7.
Miller RD. Pharmacodynamics and pharmacokinetics of anticholinesterase. In: Ruegheimer E, Zindler M, ed. Anesthesiology. (Hamburg, Germany: Congress; Sep 14-21, 1980; 222-223.) (Int Congr. No. 538), Amsterdam, Netherlands: Excerpta Medica; 1981.
8.
Breyer-Pfaff U, Maier U, Brinkmann AM, Schumm F. Pyridostigmine kinetics in healthy subjects and patients with myasthenia gravis. Clin Pharmacol Ther. 1985; 5:495-501.

Distributed by: Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada
®/™ are trademarks of Bausch Health Companies Inc. or its affiliates.
© 2020 Bausch Health Companies Inc. or its affiliates
9674001 20002622C Rev. 12/2020

PRINCIPAL DISPLAY PANEL — 473 mL Bottle Label

NDC 68682-307-05
Rx only

PYRIDOSTIGMINE
BROMIDE
ORAL
SOLUTION, USP
60 mg

5 mL (1 teaspoonful) contains
60 mg pyridostigmine bromide.

5 mL = 60 mg
1 Pint (473 mL)

Alcohol 5%

OCEANSIDE
PHARMACEUTICALS

label60mg
(click image for full-size original)
PYRIDOSTIGMINE BROMIDE pyridostigmine bromide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-307
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pyridostigmine bromide (pyridostigmine) pyridostigmine bromide 60 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
alcohol
glycerin
LACTIC ACID, UNSPECIFIED FORM
sodium benzoate
sorbitol
sucrose
FD&C Red No. 40
FD&C Blue No. 1
water
Product Characteristics
Color Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68682-307-05 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA015193 07/01/2019
Labeler — Oceanside Pharmaceuticals (832011691)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies Inc. 245141858 MANUFACTURE (68682-307)

Revised: 12/2020 Oceanside Pharmaceuticals

Page 2 of 2 1 2

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.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.