Patient Information ⮝
Patients should be advised to contact their physician if they experience any adverse reactions to Carisoprodol Tablets.
Sedation
Advise patients that Carisoprodol Tablets may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking Carisoprodol Tablets before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery [see Warnings and Precautions (5.1)].
Avoidance of Alcohol and Other CNS Depressants
Advise patients to avoid alcoholic beverages while taking Carisoprodol Tablets 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)].
Carisoprodol Tablets Should Only Be Used for Short-Term Treatment
Advise patients that treatment with Carisoprodol Tablets 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 Tablets, 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.
Lactation
Advise nursing mothers using Carisoprodol Tablets to monitor neonates for signs of sedation [see Use in Specific Populations (8.2)].
Manufactured By: ⮝
Nostrum Laboratories Inc
Kansas City, MO 64120
Rev: 01
September 2018
Package Label - Principal Display Panel 30-count Bottle, 250 mg Tablets
NDC 29033-207-30
Carisoprodol
Tablets, USP CIV
250 mg
RxOnly
30 TabletsPackage Label - Principal Display Panel 100-count Bottle, 250 mg Tablets
NDC 29033-207-01
Carisoprodol
Tablets, USP CIV
250 mg
RxOnly
100 Tablets
CARISOPRODOL
carisoprodol tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29033-207 Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARISOPRODOL(UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H) CARISOPRODOL 250 mg
Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE(UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM(UNII: M28OL1HH48) HYPROMELLOSES(UNII: 3NXW29V3WO) MAGNESIUM STEARATE(UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U) SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 10mm Flavor Imprint Code NC;250 Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:29033-207-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2017 2 NDC:29033-207-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/11/2017
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207237 05/11/2017
Labeler -Nostrum Laboratories, Inc. (791142354)
Establishment Name Address ID/FEI Business Operations Nostrum Laboratories, Inc. 791142354 MANUFACTURE(29033-207) , ANALYSIS(29033-207) , pack(29033-207)
Revised: 9/2018document Id: ⮝
9cf9d372-db0e-41a5-8d12-24f9f648964cSet id: ab22f1be-16c8-45b6-adaf-09e08bf7a545Version: 3Effective Time: 20180906Nostrum Laboratories, Inc.