Cevimeline Hydrochloride (Page 3 of 3)

MANAGEMENT OF OVERDOSAGE

Management of the signs and symptoms of acute overdosage should be handled in a manner consistent with that indicated for other muscarinic agonists: general supportive measures should be instituted. If medically indicated, atropine, an anti-cholinergic agent, may be of value as an antidote for emergency use in patients who have had an overdose of cevimeline. If medically indicated, epinephrine may also be of value in the presence of severe cardiovascular depression or bronchoconstriction. It is not known if cevimeline is dialyzable.

DOSAGE AND ADMINISTRATION

The recommended dose of cevimeline hydrochloride is 30 mg taken three times a day. There is insufficient safety information to support doses greater than 30 mg tid. There is also insufficient evidence for additional efficacy of cevimeline hydrochloride at doses greater than 30 mg tid.

HOW SUPPLIED

Cevimeline Hydrochloride Capsules are available as hard gelatin capsule with tan opaque cap and tan opaque body imprinted with “NL 999” on the cap and “30 mg” on the body with black ink, filled with white to off white granular powder.

It is supplied in:

Child-resistant bottles of 30 Capsules (NDC 40032-999-03)

Child-resistant bottles of 100 Capsules (NDC 40032-999-01)

Bottles of 500 Capsules (NDC 40032-999-05)

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/NF.

Rx Only

Manufactured by:

Novel Laboratories, Inc.

Somerset, NJ 08873

Iss. 02/2016

PI9990000101

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Labels

30 Count

30 count
(click image for full-size original)

100 Count

100 count
(click image for full-size original)

500 Count

500 count
(click image for full-size original)
CEVIMELINE HYDROCHLORIDE cevimeline hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-999
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEVIMELINE HYDROCHLORIDE (CEVIMELINE) CEVIMELINE HYDROCHLORIDE ANHYDROUS 30 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
HYDROXYPROPYL CELLULOSE (TYPE E)
MAGNESIUM STEARATE
D&C YELLOW NO. 10
FD&C RED NO. 40
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
GELATIN
SHELLAC
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
AMMONIA
Product Characteristics
Color BROWN (TAN) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code NL999;30mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-999-03 30 CAPSULE in 1 BOTTLE None
2 NDC:40032-999-01 100 CAPSULE in 1 BOTTLE None
3 NDC:40032-999-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204746 12/30/2016
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 ANALYSIS (40032-999), MANUFACTURE (40032-999), PACK (40032-999)

Revised: 02/2016 Novel Laboratories, Inc.

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