MYVLAR (GESTODENE, ETHINYL ESTRADIOL) TABLET [OASIS TRADING]

MYVLAR (GESTODENE, ETHINYL ESTRADIOL) TABLET [OASIS TRADING]
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NDC 72689-0012-1
Set ID 7b38aa8b-0cae-66b1-e053-2991aa0aeac8
Category HUMAN OTC DRUG LABEL
Packager OASIS TRADING
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Gestodene, Ethinyl Estradiol

  • PURPOSE

    Oral contraception

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    1 tab daily for 21 days; repeat.

  • WARNINGS

    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.

  • INACTIVE INGREDIENT

    Stearic acid, corn starch, polyethylene glycol 6000

  • DOSAGE & ADMINISTRATION

    For oral use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    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)

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