Carisoprodol (Page 4 of 4)

16 HOW SUPPLIED/STORAGE AND HANDLING

Carisoprodol tablets USP, 350 mg are white, round, debossed MP 58 on one side and blank on the other side.

Bottles of 20 NDC 53489-110-60
Bottles of 30 NDC 53489-110-07
Bottles of 60 NDC 53489-110-06
Bottles of 100 NDC 53489-110-01
Bottles of 500 NDC 53489-110-05
Bottles of 1000 NDC 53489-110-10

Store at 20° to 25°C (68° to 77°F).

[See USP Controlled Room Temperature]

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

17 PATIENT COUNSELING INFORMATION

Patients should be advised to contact their physician if they experience any adverse reactions to carisoprodol.

17.1 Sedation

Patients should be advised that carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking carisoprodol before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1) ].

17.2 Avoidance of Alcohol and Other CNS Depressants

Patients should be advised to avoid alcoholic beverages while taking carisoprodol and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives [see Warnings and Precautions (5.1) ].

17.3 Carisoprodol Should Only Be Used for Short-Term Treatment

Patients should be advised that treatment with carisoprodol should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.

Manufactured by:
MUTUAL PHARMACEUTICAL COMPANY, INC.
Philadelphia, PA 19124 USA

Rev 08, February 2014

PRINCIPAL DISPLAY PANEL — 100 Tablet Label

MP

NDC 53489-110-01

CARISOPRODOL
TABLETS USP
CIV
350 mg

100 TABLETS
Rx only

MUTUAL PHARMACEUTICAL CO., INC. PHILADELPHIA, PA 19124 USA

Principal Display Panel -- 100 Tablet Label
(click image for full-size original)
CARISOPRODOL carisoprodol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53489-110
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carisoprodol (Carisoprodol) Carisoprodol 350 mg
Inactive Ingredients
Ingredient Name Strength
starch, corn
lactose
magnesium stearate
povidones
sodium lauryl sulfate
sodium starch glycolate type a potato
stearic acid
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 12mm
Flavor Imprint Code MP;58
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53489-110-60 20 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:53489-110-07 30 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:53489-110-06 60 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:53489-110-01 100 TABLET in 1 BOTTLE, PLASTIC None
5 NDC:53489-110-05 500 TABLET in 1 BOTTLE, PLASTIC None
6 NDC:53489-110-10 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089346 10/17/1991
Labeler — Mutual Pharmaceutical Company, Inc. (121735955)

Revised: 02/2014 Mutual Pharmaceutical Company, Inc.

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.