Robaxin Images

IMAGES

West-Ward 290

Color: white

Shape: round

Imprint: West-Ward 290

WEST-WARD 292

Color: white

Shape: oblong

Imprint: WEST-WARD 292

 

4211 V

Color: white

Shape: round

Imprint: 4211 V

 

1 of 2

4212, V

Color: white

Shape: oblong

Imprint: 4212, V

 

114, H

Color: white

Shape: oval

Imprint: 114, H

 

115, H

Color: white

Shape: oval

Imprint: 115, H

 

Color: white

Shape: round

 

S226

Color: white

Shape: capsule

Imprint: S226

 

AP212, bisected

Color: orange

Shape: round

Imprint: AP212, bisected

 

AP211

Color: yellow

Shape: capsule

Imprint: AP211

 

AP212

Color: orange

Shape: round

Form: film coated

Imprint: AP212

 

LL, M 19

Color: white

Shape: round

Imprint: LL, M 19

 

GG 190

Color: white

Shape: round

Imprint: GG 190

 

5381, DAN DAN

Color: white

Shape: round

Imprint: 5381, DAN DAN

 

S 225

Color: white

Shape: round

Imprint: S 225

 

AP211

Color: yellow

Shape: oval

Form: film coated

Imprint: AP211

 

LL, M 20

Color: white

Shape: oblong

Imprint: LL, M 20

 

GG 101

Color: white

Shape: oblong

Imprint: GG 101

 

5382, DAN DAN

Color: white

Shape: oblong

Imprint: 5382, DAN DAN

 

S 226

Color: white

Shape: capsule

Imprint: S 226

 

AHR, ROBAXIN 750

Color: orange

Shape: oblong

Imprint: AHR, ROBAXIN 750

NO IMAGE AVAILABLE

612, O

Color: white

Shape: capsule

Imprint: 612, O

methocarbamol Clinical Pharmacology

The mechanism of action of methocarbamol in humans has not been established, but may be due to general CNS depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Pharmacokinetics

In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.

Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine.

Special Populations

Elderly

The mean (± SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), healthy population (1.5 (± 0.4) hours versus 1.1 (± 0.27) hours, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).

Renally Impaired

The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (± SD) elimination half-life in these two groups was similar (1.2 (± 0.6) versus 1.1 (± 0.3) hours, respectively).

Hepatically Impaired

In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (± SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (± 1.62) hours and 1.11 (± 0.27) hours respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.

How to Properly Use Robaxin ?

This section provides information on the proper use of a number of products that contain methocarbamol. It may not be specific to Robaxin. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For relaxing stiff muscles:
      • Adults—At first, three tablets of 500 milligrams (mg) or two tablets of 750 mg (total dose of 1500 mg) four times a day. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

What You Should Know Before You Take Robaxin ?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of methocarbamol in children below 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of methocarbamol in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

      • Alfentanil
      • Alprazolam
      • Amobarbital
      • Aprobarbital
      • Benzhydrocodone
      • Bromazepam
      • Buprenorphine
      • Butabarbital
      • Butalbital
      • Butorphanol
      • Calcium Oxybate
      • Cannabidiol
      • Carisoprodol
      • Cetirizine
      • Chloral Hydrate
      • Chlordiazepoxide
      • Chlorzoxazone
      • Clobazam
      • Clonazepam
      • Clorazepate
      • Codeine
      • Dantrolene
      • Daridorexant
      • Diazepam
      • Dihydrocodeine
      • Doxylamine
      • Esketamine
      • Estazolam
      • Ethchlorvynol
      • Fentanyl
      • Flibanserin
      • Flunitrazepam
      • Flurazepam
      • Gabapentin
      • Gabapentin Enacarbil
      • Halazepam
      • Hydrocodone
      • Hydromorphone
      • Ketamine
      • Ketazolam
      • Lemborexant
      • Levocetirizine
      • Levorphanol
      • Lofexidine
      • Lorazepam
      • Lormetazepam
      • Loxapine
      • Magnesium Oxybate
      • Medazepam
      • Meperidine
      • Mephenesin
      • Mephobarbital
      • Meprobamate
      • Metaxalone
      • Methadone
      • Methohexital
      • Metoclopramide
      • Midazolam
      • Morphine
      • Morphine Sulfate Liposome
      • Nalbuphine
      • Nitrazepam
      • Oxazepam
      • Oxycodone
      • Oxymorphone
      • Pentazocine
      • Pentobarbital
      • Periciazine
      • Phenobarbital
      • Potassium Oxybate
      • Prazepam
      • Pregabalin
      • Primidone
      • Quazepam
      • Remifentanil
      • Remimazolam
      • Ropeginterferon Alfa-2b-njft
      • Scopolamine
      • Secobarbital
      • Sodium Oxybate
      • Sufentanil
      • Tapentadol
      • Temazepam
      • Thiopental
      • Tramadol
      • Trazodone
      • Triazolam
      • Zolpidem

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

      • Kidney disease or
      • Liver disease—Use with caution. The effects of this medicine may be increased because of slower removal from the body.
      • Myasthenia gravis—Use with caution. May make this condition worse.

Reumofan Plus Dietary Supplement Relabeled and Sold as “WOW”: Public Warning – Undeclared Drug Ingredients

ISSUE: The U.S. Food and Drug Administration (FDA) is warning the public that the potentially harmful dietary supplement product Reumofan Plus is being relabeled and sold under the name “WOW.”

The product is being marketed to treat arthritis, muscle pain, osteoporosis, bone cancer, and other conditions.

he chemical name of methocarbamol is 3-(2-methoxyphenoxy) -1,2propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24.
he chemical name of methocarbamol is 3-(2-methoxyphenoxy) -1,2propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24.

FDA laboratory analysis confirmed that “WOW” contains the same prescription drug ingredients that are in Reumofan Plus, including dexamethasone (a corticosteroid), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocarbamol (a muscle relaxant).

These ingredients have the potential to cause serious injury.

BACKGROUND: FDA warned the public of the harm of Reumofan Plus on June 1, 2012, and again on August 21, 2012.  Since June, FDA has received dozens of adverse event reports, many of them serious, from consumers who used Reumofan Plus.  The reports include liver injury, severe bleeding, corticosteroid withdrawal syndrome, adrenal suppression, stroke, and even death.

Reumofan Plus and “WOW” products are sold on various websites, including Gonepainfree.com and Browerent.com. The products are manufactured by Riger Naturals S.A.

In addition to websites selling “WOW,” FDA has become aware that various websites, including Reumofanusa.com, owned by Reumofan USA, LLC, continue to sell Reumofan Plus even after previous FDA warnings. Please see the link to the FDA public warning for product photos.

RECOMMENDATION: Consumers currently taking or who have taken Reumofan Plus or “WOW” should immediately consult a health care professional.  Health care professionals are urged to ask their patients about the use of Reumofan Plus, “WOW,” and other similar products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, psychiatric changes, or the use or abrupt discontinuation of corticosteroids.

Additionally, health care professionals should evaluate patients who have used Reumofan Plus and/or WOW for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of Reumofan Plus products and “WOW” to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

      • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
      • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as “two to four tablets four times daily” rather than the correct dosage of “two tablets three times daily.” (see picture below for location of incorrect text).

Patients who follow the directions on the bottle may experience significant drowsiness or dizziness which would put them at risk of falls or an overdose which could result in seizures, coma, or death. To date, Endo Pharmaceuticals Inc. has not received any reports of adverse events related to this recall.

Robaxin® 750mg Tablets contain the active ingredient methocarbamol and are indicated as an adjunct therapy to rest, physical therapy and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. Robaxin® 750mg Tablets are packed in bottles of 100 tablets with package labeling featuring the product name, strength, lot number, expiry date and the National Drug Code number NDC 52244-449-10.

The recall includes the following product lots:

    • Robaxin® 750mg, 100 Count Bottle pack, Lot 216702P1, Expiration Date: September 2020; and
    • Robaxin® 750mg, 100 Count Bottle pack, Lot 220409P1, Expiration Date: January 2021.

No other lots of Robaxin® are affected by this market action.

Robaxin® 750mg 100 Count Bottle packs were distributed by wholesale distributors to retail pharmacies.

Endo Pharmaceuticals Inc. is notifying distributors and retailers in writing through Inmar, Inc. Inmar is arranging for return of all recalled products.

Distributors and retailers that have product which is being recalled should stop distributing and dispensing and return to the place of purchase.

Consumers in possession of any unused prescribed Robaxin® 750mg product bearing lot numbers 216702P1 or 220409P1 should discontinue use of the product and return the unused product by following the instructions below:

  • Please contact Inmar at 1-866-391-0620, Monday through Friday (9am to 5pm ET) or email robaxin@inmar.com for the following:
    • Product Return
      • Upon contacting Inmar and indicating you have unused product, please expect Return Authorization labels and Shipping instructions.
    • Product Reimbursement
      • Upon contacting Inmar, please be prepared to share proof of purchase.
        • Proof of purchase can be sent to robaxin@inmar.com or 635 Vine St.Winston Salem, NC 27101-Attention Recall Department, Robaxin Recall.

Distributors, retailers and consumers with questions regarding this recall can contact Inmar by telephone at 1-866-391-0620 during the following hours: Monday through Friday (9am to 5pm ET) or by email at robaxin@inmar.com.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

  • Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
  • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This Product Recall is being made with the knowledge of the United States Food and Drug Administration (FDA).

Endo Pharmaceuticals Inc. takes this issue seriously and works to achieve high quality standards for all of its products and packaging. If you have any questions, please call 1-800-462-ENDO (3636), between the hours of 8:00 a.m. to 8:00 p.m. ET Monday through Thursday and 8:00 a.m. to 6:00 p.m. ET on Friday. Additional information regarding this recall can be found at http://www.endo.com/endopharma/our-products.

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect Strength

October 19, 2021 — Burbank, CA, Bryant Ranch Prepack is voluntarily recalling 1 lot of Methocarbamol 500mg, Tablets to the consumer level. The bottles labeled as Methocarbamol 500mg Tablets have been found to contain Methocarbamol 750mg Tablets.

Risk Statement: If a patient takes a 750mg Tablet of Methocarbamol instead of the prescribed 500mg Tablets, it potentially could result in Excessive Central Nervous System depression which may result in nausea, sedation, fainting, falls, seizure, coma, and death. Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

The product is used together with rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.

The product is packaged in a white round bottle with a red and white label, which reads Methocarbamol 500mg packaged in counts of 30 (NDC:7133517952), 60 (NDC: 7133517954), and 90 (NDC:7133517957) pills. The affected Methocarbamol 500mg lots include the following Lot Number 163935/ Exp. Date 10/22. The product can be identified by red and white label with a yellow border at the top and bottom of the label, top of the label reads “Packaged by Bryant Ranch Prepack”, labels are pictured here. The Methocarbamol 500mg was distributed Nationwide to multiple physician offices.

Bryant Ranch Prepack is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Consumers that have the bottles labeled as Methocarbamol 500mg Tablets which is being recalled should stop using immediately and return to place of purchase and/or contact their physician. Distributors/Physicians should stop distribution and contact Bryant Ranch Prepack to return the product immediately.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack by phone at 877-885-0882 Mon.-Fri. 7am-6pm PST or compliance@brppharma.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA