Lomotil (Page 3 of 3)

HOW SUPPLIED

Tablets —round, white, with SEARLE debossed on one side and 61 on the other side and containing 2.5 mg of diphenoxylate hydrochloride and 0.025 mg of atropine sulfate, supplied as:

NDC Number Size

54868-0427-5 bottle of 10

54868-0427-4 bottle of 12

54868-0427-3 bottle of 30

54868-0427-0 bottle of 100

Rx only

Lomotil Tablets

image of 2 package labels (2_a)
(click image for full-size original)
image of 2 package labels (2_b)
(click image for full-size original)
LOMOTIL
diphenoxylate hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0427(NDC:0025-0061)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE) DIPHENOXYLATE HYDROCHLORIDE 2.5 mg
ATROPINE SULFATE (ATROPINE) ATROPINE SULFATE 0.025 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA
STARCH, CORN
MAGNESIUM STEARATE
SORBITOL
SUCROSE
TALC
Product Characteristics
Color white (white) Score no score
Shape ROUND (round) Size 6mm
Flavor Imprint Code SEARLE;61
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0427-5 10 TABLET (TABLET) in 1 BOTTLE None
2 NDC:54868-0427-4 12 TABLET (TABLET) in 1 BOTTLE None
3 NDC:54868-0427-3 30 TABLET (TABLET) in 1 BOTTLE None
4 NDC:54868-0427-0 100 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA012462 01/19/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 repack, relabel

Revised: 09/2009 Physicians Total Care, Inc.

Page 3 of 3 1 2 3

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 © 2020. All Rights Reserved.