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CARISOPRODOL- carisoprodol tablet


  1. Patient Information
  2. Manufactured By:
  3. Revised: 9/2018document Id:

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 Tablets

Package Label - Principal Display Panel     30-count Bottle, 250 mg Tablets

Package Label - Principal Display Panel 100-count Bottle, 250 mg Tablets

NDC 29033-207-01
Carisoprodol
Tablets, USP CIV
250 mg
RxOnly
100 Tablets

Package Label - Principal Display Panel     100-count Carton, 250 mg Tablets

CARISOPRODOL
carisoprodol tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:29033-207
Route of AdministrationORALDEA ScheduleCIV
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARISOPRODOL(UNII: 21925K482H) (CARISOPRODOL - UNII:21925K482H)CARISOPRODOL250 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize10mm
FlavorImprint CodeNC;250
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29033-207-3030 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
2NDC:29033-207-01100 in 1 BOTTLE; Type 0: Not a Combination Product05/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20723705/11/2017
Labeler -Nostrum Laboratories, Inc. (791142354)
Establishment
NameAddressID/FEIBusiness Operations
Nostrum Laboratories, Inc.791142354MANUFACTURE(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.



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