Dicyclomine Hydrochloride (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 10 mg Capsules

NDC 51079-118-20

Dicyclomine
Hydrochloride
Capsules, USP
10 mg

100 Capsules (10 x 10)

Each capsule contains:
Dicyclomine
hydrochloride, USP 10 mg

Usual Dosage: See accompanying
prescribing information.

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

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-7081 R5

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Dicyclomine Hydrochloride 10 mg Capsules Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Tablets

NDC 51079-119-20

Dicyclomine
Hydrochloride
Tablets, USP
20 mg

100 Tablets (10 x 10)

Each tablet contains:
Dicyclomine
hydrochloride, USP 20 mg

Usual Dosage: See accompanying
prescribing information.

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

To prevent fading, avoid
exposure to direct sunlight.

Manufactured by:
Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Rx only

S-7072 R5

Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Dicyclomine Hydrochloride 20 mg Tablets Unit Carton Label
(click image for full-size original)
Serialized Unit Carton
(click image for full-size original)
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-118(NDC:0378-1610)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
FD&C BLUE NO. 2
FD&C RED NO. 40
GELATIN, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SHELLAC
STARCH, CORN
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
Product Characteristics
Color turquoise (light turquoise blue opaque) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code MYLAN;1610
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-118-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-118-01)
1 NDC:51079-118-01 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (51079-118-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040319 12/01/1999 12/31/2019
DICYCLOMINE HYDROCHLORIDE dicyclomine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-119(NDC:0378-1620)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE) DICYCLOMINE HYDROCHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
SILICON DIOXIDE
FD&C BLUE NO. 1
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
STARCH, CORN
Product Characteristics
Color blue Score no score
Shape ROUND Size 7mm
Flavor Imprint Code M;D6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51079-119-20 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (51079-119-01)
1 NDC:51079-119-01 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (51079-119-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040317 03/06/1998 11/30/2020
Labeler — Mylan Institutional Inc. (039615992)

Revised: 02/2020 Mylan Institutional Inc.

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