Rx Item-Emverm 100MG Mebendazole 1 Chewable Tab by Amneal

Rx Item-Emverm 100MG 1 Chewable by Amneal Pharma USA Specialty , Clinical Information:
Generic Code And Description: 9607 Mebendazole Oral Tab Chewable 100 Mg
Strength: 100 Mg
Dose Form: Tablet Chewable
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 8080000 Anthelmintics
Active Ingredients: 2987 Mebendazole 31431397
Inactive Ingredients: 10143 Yellow Dye
2432 Lactose 64044515
2600 Saccharin 81072 Drug Class: Drug Class: 8080000 Anthelmintics, OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 1 , Brand Label Flag: BRAND , Storage Temperature Zone: 10 Room Temperature, Item Size Code:1 , Item Strength Code:100MG , Item Abbreviation: Emverm , Generic Form: CHW

These highlights do not include all the information needed to use EMVERM® safely and effectively. See full prescribing information for EMVERM®.

EMVERM® (mebendazole) chewable tablets, for oral use
Initial U.S. Approval: 1974
INDICATIONS AND USAGE

EMVERM® is an anthelmintic indicated for the treatment of patients two years of age and older with gastrointestinal infections caused by:

Ancylostoma duodenale (hookworm),

Ascaris lumbricoides (roundworm),

Enterobius vermicularis (pinworm),

Necator americanus (hookworm), and

Trichuris trichiura (whipworm), (1).

DOSAGE AND ADMINISTRATION

Adults and Pediatrics: The tablet may be chewed, swallowed, or crushed and mixed with food (2).


Pinworm (enterobiasis)


Whipworm (trichuriasis)


Roundworm (ascariasis)


Hookworm

Dose


1 tablet once


1 tablet morning and evening for 3 consecutive days


1 tablet morning and evening for 3 consecutive days


1 tablet morning and evening for 3 consecutive days

DOSAGE FORMS AND STRENGTHS

Chewable Tablet: 100 mg (3)

CONTRAINDICATIONS

Patients with a known hypersensitivity to the drug or its excipients (4)

WARNINGS AND PRECAUTIONS

Risk of Convulsions: Convulsions in infants below the age of 1 year have been reported (5.1).
Hematologic Effects: Neutropenia and agranulocytosis have been reported in patients receiving mebendazole at higher doses and for prolonged duration. Monitor blood counts in these patients (5.2).
Metronidazole and Serious Skin Reactions: Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) have been reported with the concomitant use of mebendazole and metronidazole. Avoid concomitant use of mebendazole and metronidazole (5.3).

ADVERSE REACTIONS

Adverse reactions reported in clinical trials were anorexia, abdominal pain, diarrhea, flatulence, nausea, vomiting and rash (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 8/2021

Rx Item-Emverm 100MG 1 Chewable by Amnea
Item No. RX713917, 713917, NDC No.: 64896-0669-30, 64896-669-30, 6489666930, 64896066930, 0669-30, 066930 UPC No. 3-64896-66930-8, 364896-669308, 364896669308

Rx Item-Emverm 100MG 1 Chewable by Amnea
Item No. RX713917, 713917, NDC No.: 64896-0669-30, 64896-669-30, 6489666930, 64896066930, 0669-30, 066930 UPC No. 3-64896-66930-8, 364896-669308, 364896669308

Rx Item-Emverm 100MG 1 Chewable by Amnea
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica