MYVLAR- gestodene, ethinyl estradiol tablet 
OASIS TRADING

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Gestodene, Ethinyl Estradiol

Oral contraception

Keep out of reach of children

1 tab daily for 21 days; repeat.

Warnings/Precautions:
Smokers over 35yrs of age: not recommended. Uncontrolled hypertension. Hypertriglyceridemia. Discontinue if jaundice, visual disturbances, migraine or other severe headaches occur. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see literature). Nursing mothers: not recommended
Contraindications
Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic adenoma or carcinoma. Pregnancy (Cat.X).
Interactions
Antagonized by hepatic enzyme inducing drugs (eg, rifampin, griseofulvin, St. John's wort), possibly others. May affect measurement of sex hormone-binding globulin levels
Adverse Reactions:
Hypertension, nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, mastodynia, headache, intolerance to contact lenses. Increased risk of gallbladder disease, thromboembolic disorders.

Stearic acid, corn starch, polyethylene glycol 6000

For oral use only

label

MYVLAR 
gestodene, ethinyl estradiol tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0012
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GESTODENE (UNII: 1664P6E6MI) (GESTODENE - UNII:1664P6E6MI) GESTODENE0.075 mg
ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U) ETHINYL ESTRADIOL0.03 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72689-0012-121 in 1 BLISTER PACK; Type 0: Not a Combination Product11/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/22/2018
Labeler - OASIS TRADING (689991468)
Registrant - OASIS TRADING (689991468)
Establishment
NameAddressID/FEIBusiness Operations
OASIS TRADING689991468manufacture(72689-0012) , label(72689-0012)

Revised: 11/2018
Document Id: 7b38aa8b-0caf-66b1-e053-2991aa0aeac8
Set id: 7b38aa8b-0cae-66b1-e053-2991aa0aeac8
Version: 1
Effective Time: 20181121
 
OASIS TRADING