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 available as follows:

5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with PLIVA/323 on

the scored side and plain on the other side.
Available in bottles of 100 (NDC 50111-323-01).

10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with PLIVA/324 on

the scored side and plain on the other side.
Available in bottles of 100 (NDC 50111-324-01).

25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with PLIVA/325 on

the scored side and plain on the other side.
Available in bottles of 100 (NDC 50111-325-01).

50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with PLIVA/326 on

the scored side and plain on the other side.
Available in bottles of 100 (NDC 50111-326-01).

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

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

TEVA PHARMACEUTICALS USA, INC.

North Wales, PA 19454

Rev. A 9/2015

Package/Label Display Panel

Bethanechol Chloride Tablets USP 5 mg 100s Label
(click image for full-size original)

Bethanechol Chloride Tablets USP 5 mg 100s Label Text

NDC 50111-323 -01

Bethanechol
Chloroide
Tablets USP
5 mg

Rx only

100 TABLETS

TEVA

Package/Label Display Panel

Bethanechol Chloride Tablets USP 10 mg 100s Label
(click image for full-size original)

Bethanechol Chloride Tablets USP 10 mg 100s Label Text

NDC 50111-324 -01

Bethanechol
Chloride
Tablets USP
10 mg

Rx only

100 TABLETS

TEVA

Package/Label Display Panel

Bethanechol Chloride Tablets USP 25 mg 100s Label
(click image for full-size original)

Bethanechol Chloride Tablets USP 25 mg 100s Label Text

NDC 50111-325 -01

Bethanechol
Chloride
Tablets USP
25 mg

Rx only

100 TABLETS

TEVA

Package/Label Display Panel

Bethanechol Chloride Tablets USP 50 mg 100s Label
(click image for full-size original)

Bethanechol Chloride Tablets USP 50 mg 100s Label Text

NDC 50111-326 -01

Bethanechol
Chloride
Tablets, USP
50 mg

Rx only

100 TABLETS

TEVA

BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-323
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;323
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50111-323-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089095 09/30/1990
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-324
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;324
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50111-324-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088440 09/30/1990
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-325
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;325
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50111-325-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088441 09/30/1990
BETHANECHOL CHLORIDE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50111-326
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
Product Characteristics
Color YELLOW Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code PLIVA;326
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50111-326-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089096 09/30/1990
Labeler — Pliva Inc. (001627975)

Revised: 03/2016 Pliva Inc.

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