Urecholine (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

Urecholine® (Bethanechol Chloride Tablets USP) is available as follows:

5 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/697 on the

scored side and plain on the other side.
Available in bottles of 100 (NDC 51285-697-02).

10 mg: White, round, flat-face, beveled edge, scored tablet. Debossed with OP/703 on the

scored side and plain on the other side.
Available in bottles of 100 (NDC 51285-690-02).

25 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/704 on the

scored side and plain on the other side.
Available in bottles of 100 (NDC 51285-691-02).

50 mg: Yellow, round, flat-face, beveled edge, scored tablet. Debossed with OP/700 on the

scored side and plain on the other side.
Available in bottles of 100 (NDC 51285-692-02).

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

Urecholine® (bethanechol chloride tablets USP) 5 mg, 100s Label
(click image for full-size original)

Urecholine® (bethanechol chloride tablets USP) 5 mg 100s Label Text

NDC 51285-697 -02

Urecholine®
(bethanechol chloride tablets USP)

5 mg

100 Tablets

TEVA

Rx only

Package/Label Display Panel

Urecholine® (bethanechol chloride tablets USP) 10 mg, 100s Label
(click image for full-size original)

Urecholine® (bethanechol chloride tablets USP) 10 mg 100s Label Text

NDC 51285-690- 02

Urecholine®
(bethanechol chloride tablets USP)

10 mg

100 Tablets

TEVA

Rx only

Package/Label Display Panel

Urecholine® (bethanechol chloride tablets USP) 25 mg, 100s Label
(click image for full-size original)

Urecholine® (bethanechol chloride tablets USP) 25 mg 100s Label Text

NDC 51285-691- 02

Urecholine®
(bethanechol chloride tablets USP)

25 mg

100 Tablets

TEVA

Rx only

Package/Label Display Panel

Urecholine® (bethanechol chloride tablets USP) 50 mg, 100s Label
(click image for full-size original)

Urecholine® (bethanechol chloride tablets USP) 50 mg 100s Label Text

NDC 51285-692- 02

Urecholine®
(bethanechol chloride tablets USP)

50 mg

100 Tablets

TEVA

Rx only

URECHOLINE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51285-697
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code OP;697
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51285-697-02 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089095 02/01/2001
URECHOLINE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51285-690
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code OP;703
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51285-690-02 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088440 02/01/2001
URECHOLINE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51285-691
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
MICROCRYSTALLINE CELLULOSE
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 OP;704
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51285-691-02 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088441 04/01/2000
URECHOLINE
bethanechol chloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51285-692
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
MICROCRYSTALLINE CELLULOSE
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 OP;700
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51285-692-02 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089096 02/01/2001
Labeler — Teva Women’s Health, Inc. (017038951)

Revised: 12/2017 Teva Women’s Health, Inc.

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