Bethanechol Chloride (Page 2 of 2)

DOSAGE AND ADMINISTRATION:

Dosage must be individualized, depending on the type and severity of the condition to be treated.

Preferably give the drug when the stomach is empty. If taken soon after eating, nausea and vomiting may occur.

The usual adult oral dose ranges from 10 to 50 mg three or four times a day. The minimum effective dose is determined by giving 5 to 10 mg initially and repeating the same amount at hourly intervals until satisfactory response occurs, or until a maximum of 50 mg has been given. The effects of the drug sometimes appear within 30 minutes and are usually maximal within 60 to 90 minutes. The drug effects persist for about one hour.

If necessary, the effects of the drug can be abolished promptly by atropine (see OVERDOSAGE).

HOW SUPPLIED:

Bethanechol Chloride Tablets, USP are supplied as follows:

5 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1332 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 0527-1332-01.

10 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1340 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 0527-1340-01.

25 mg tablets: off-white, round, flat-faced beveled edge, bisected tablets debossed LCI over 1356 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 0527-1356-01.

50 mg tablets: yellow, round, flat-faced beveled edge, bisected tablets debossed LCI over 1329 on one side and plain on the other side.

They are supplied in bottles of 100 tablets; NDC 0527-1329-01.

Dispense in a tight container as defined in the USP with a child resistant closure.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

CIB70471D

Rev. 03/20

PRINCIPAL DISPLAY PANEL — 5 mg Container Label

NDC 0527-1332 -01

Bethanechol
Chloride
Tablets, USP

5 mg

Rx Only

100 Tablets

Lannett

5 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Container Label

NDC 0527-1340 -01

Bethanechol
Chloride
Tablets, USP

10 mg

Rx Only

100 Tablets

Lannett

10 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg Container Label

NDC 0527-1356 -01

Bethanechol
Chloride
Tablets, USP

25 mg

Rx Only

100 Tablets

Lannett

25 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Container Label

NDC 0527-1329 -01

Bethanechol
Chloride
Tablets, USP

50 mg

Rx Only

100 Tablets

Lannett

50 mg
(click image for full-size original)
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1332
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1332
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1332-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1340
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1340
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1340-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1356
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1356
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1356-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1329
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BETHANECHOL CHLORIDE (BETHANECHOL) BETHANECHOL CHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE B POTATO
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
D&C YELLOW NO. 10
ALUMINUM OXIDE
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code LCI;1329
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1329-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040677 03/27/2008
Labeler — Lannett Company, Inc. (002277481)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 829757603 ANALYSIS (0527-1332), ANALYSIS (0527-1340), ANALYSIS (0527-1356), ANALYSIS (0527-1329)
Establishment
Name Address ID/FEI Operations
Lannett Company, Inc. 006422406 LABEL (0527-1332), LABEL (0527-1340), LABEL (0527-1356), LABEL (0527-1329), MANUFACTURE (0527-1332), MANUFACTURE (0527-1340), MANUFACTURE (0527-1356), MANUFACTURE (0527-1329), PACK (0527-1332), PACK (0527-1340), PACK (0527-1356), PACK (0527-1329), RELABEL (0527-1332), RELABEL (0527-1340), RELABEL (0527-1356), RELABEL (0527-1329), REPACK (0527-1332), REPACK (0527-1340), REPACK (0527-1356), REPACK (0527-1329)

Revised: 03/2020 Lannett Company, Inc.

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